[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lupus-erythematosus-systemic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lupus-erythematosus-systemic":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,49,72,111,134,157,179,204,230,258,292,320,347,386,412,443,471,503,536,560,583,604,628,651,671],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100585097","phase-1-a-study-to-investigate-the-safety-tolerability-and-efficacy-of-azd0120-in-adults-with-refractory-sle-100585097",false,"NCT06897930","A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE","A Phase 1b\u002F2 Study of AZD0120, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Refractory Systemic Lupus Erythematosus (SLE)","INCLUSION:\n\n1. Males or females aged 18 through 70 years inclusive at the time of consent.\n2. Written informed consent in accordance with federal, local, and institutional guidelines.\n3. Must be able and willing to adhere to the study visit schedule and other protocol requirements\n4. Adequate hepatic, renal, pulmonary, and cardiac function\n5. Have a clinical diagnosis of SLE according to the EULAR\u002F American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10.\n6. Have used at least two standard immunosuppressants (including one biological agent).\n7. SLEDAI-2K score ≥6 at screening.\n8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.\n9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN\u002FRPS classification.\n\nEXCLUSION:\n\n1. Have received prior treatment with CAR T therapy directed at any target.\n2. Have received any therapy that is targeted to CD19 and\u002For BCMA\n3. Received allogenic stem cell transplant or autologous stem cell transplant.\n4. An active malignancy that is progressing or requires active treatment.\n5. Primary immunodeficiency\n6. Active viral or bacterial infection","ALL","18 Years","70 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a Phase 1b\u002F2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19\u002FBCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.",[29],"Lupus Erythematosus, Systemic",[31,32,33,34,35],"AZD0120","SLE","Systemic Lupus Erythematosus","Lupus","Lupus Nephritis","RECRUITING","2026-08-11",{"date":39,"type":40},"2026-08-12","ACTUAL",{"date":42,"type":40},"2025-04-21",{"date":44,"type":22},"2029-05-01",{"name":46,"class":47},"AstraZeneca","INDUSTRY",20,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100640281","phase-1-to-evaluate-the-effects-of-cevostamab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640281","NCT07629583","To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","Inclusion Criteria:\n\n* Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criteria at least 6 months prior to the first screening visit\n* Active biopsy-proven LN established within 9 months of screening, demonstrating LN per 2018 Revised International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria\n* Diagnosis of active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* Inadequate response or intolerance to, in the investigator's judgement, standard of care regimens for active SLE with or without LN\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Treatment with investigational or non-investigational biologic therapies that directly deplete B cells (e.g., anti-CD20 or anti-CD19 monoclonal antibodies) (or blinded comparators) is prohibited within 6 months or 5 drug elimination half-lives, whichever is longer, prior to screening and during the study\n* Treatment with investigational biologic therapies that do not directly deplete B cells (or blinded comparators) is prohibited within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug and during the study\n* Treatment of SLE\u002FLN with non-investigational biologic therapies that do not directly deplete B cells (e.g., belimumab, anifrolumab) is prohibited within 4 weeks prior to screening and during the study\n* Treatment with CYC within 3 months prior to screening or during the study\n* History of known or suspected allergic reaction or anaphylactic reaction to cevostamab or its excipients\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* History of serious recurrent or chronic infection\n* Tuberculosis (TB) infection\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease, which, in the opinion of the investigator, is likely to require treatment with protocol-prohibited therapies\n* Non-SLE related CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease","75 Years",{"count":58,"type":22},46,[25],"The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).",[29],"2026-08-05",{"date":64,"type":40},"2026-08-07",{"date":66,"type":22},"2026-10-31",{"date":68,"type":22},"2030-03-29",{"name":70,"class":47},"Genentech, Inc.",1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100587219","phase-1-a-safety-and-efficacy-study-evaluating-ctx112-in-adult-subjects-with-refractory-autoimmune-disease-100587219","NCT06925542","A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease","A Phase 1 Dose Evaluation Study of the Safety and Preliminary Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Subjects With Refractory Autoimmune Disease","Key Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C 70 years of age.\n2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements.\n3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function.\n4. Subjects must agree to use acceptable methods of contraception.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures.\n6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM).\n\nFor systemic lupus erythematosus (SLE) subjects:\n\n\\- Diagnosis of SLE by a board-certified rheumatologist that conforms with 2019 ACR\u002FEULAR criteria. For lupus nephritis subjects, active, biopsy-proven proliferative lupus nephritis Class III or IV, either with or without the presence of Class V, and appropriate National Institutes of Health index activity score using the 2018 International Society of Nephrology\u002FRenal Pathology Society criteria.\n\nFor Systemic Sclerosis (SSc) subjects:\n\n\\- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSC) or SSc-ILD that conforms with 2013 ACR\u002FEULAR criteria. Subjects should meet active skin or lung disease criteria.\n\nFor Idiopathic Inflammatory Myopathy (IIM) subjects:\n\n\\- Diagnosis with dermatomyositis (DM), polymyositis (PM) or myositis as part of rheumatologic overlap syndrome, antisynthetase (ASyS), or immune-mediated necrotizing myopathy (IMNM) that conforms with 2017 ACR\u002FEULAR criteria for inflammatory myopathies. Subjects must meet moderate severe, skin, or lung involvement criteria.\n\nKey Exclusion Criteria:\n\n1. Prior anti-CD19 therapy or any gene therapy\u002Fgenetically modified cell therapy.\n2. Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.\n3. Severe active or history of central nervous (CNS) involvement.\n4. History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM.\n5. Mixed connective tissue disease with no clear predominant disease.\n6. Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and\u002For confound disease assessments, or pose significant risk to those receiving CAR T cell therapy.\n7. History of primary or secondary immunodeficiency.\n8. Presence or history of certain bacterial, viral or fungal infection.\n9. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence).\n10. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome.\n11. History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation.\n12. Pregnant or lactating.\n13. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.",{"count":80,"type":22},80,[25],"This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).",[84,29,35,85,86,87,88],"SLE (Systemic Lupus)","Systemic Sclerosis","Inflammatory Myopathy, Idiopathic","Myositis","Diffuse Cutaneous Systemic Sclerosis",[90,34,32,35,91,92,93,94,87,95,96,97,98,99,100,101,102],"CAR T","Allogeneic","CD19","Cell Therapy","Scleroderma","Systemic sclerosis","Idiopathic Inflammatory Myopathy","Inflammatory Myopathy","Diffused Cutaneous Systemic Sclerosis","Gene Therapy","Autoimmune","SSc","IIM",{"date":64,"type":40},{"date":105,"type":40},"2025-03-10",{"date":107,"type":22},"2031-12-31",{"name":109,"class":47},"CRISPR Therapeutics",14,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100650859","phase-3-a-study-of-outcomes-in-chinese-patients-treated-with-anifrolumab-who-have-active-mod-severe-systemic-lupus-erythematosus-100650859","NCT07751848","A Study of Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Mod-severe Systemic Lupus Erythematosus","Multicentre, Open-Label, Single-Arm, 52-Week, Ph3b Study to Evaluate the Efficacy and Safety Outcomes in Chinese Patients Treated With Anifrolumab Who Have Active Moderate-Severe Systemic Lupus Erythematosus (SLE)","LOTUS","Inclusion Criteria:\n\n* Informed Consent\n\n  1. Capable of giving signed informed consent. Age\n  2. Participant must be 18 to 70 years of age inclusive, at the time of signing the ICF.\n\n     Disease Characteristics\n  3. Participants who have a diagnosis of SLE according to the 2019 EULAR\u002FAmerican College of Rheumatology (ACR) criteria (Appendix D), confirmed by a rheumatologist\n  4. ANA-positive as determined by a documented historical test result confirmed at Screening, for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80), or at least one of the following:\n\n     1. Anti-dsDNA (b) Anti-Smith (anti-Sm) Note: Retesting of autoantibodies is allowed once during Screening.\n  5. To be eligible a participant must have SLEDAI-2K ≥6 or clinical SLEDAI-2K ≥ 4 points:\n\n     1. In order to qualify for SLEDAI-2K score for arthritis at Screening, participant must have at least 3 joints with tenderness AND swelling (same joints) due to SLE.\n     2. In order to qualify for SLEDAI-2K score for rash at Screening, participant must have rash with significant erythema (not only faint pink erythema)\n     3. Clinical SLEDAI-2K points at Screening cannot only be due to one of the following (but a combination is permitted): fever, diffuse alopecia or mucosal ulcers. NB. Presence of fever or mucosal ulcers must be documented by the investigator at the visit. Patchy alopecia which includes a change in normal scalp colour, is permitted as a sole contributor to Clinical SLEDAI-2K score.\n  6. PGA score ≥ 1.0 on a 0 to 3 visual analogue scale (VAS) at Screening.\n  7. Must be receiving at least one of the following standard therapy regimens at Screening:\n\n     a) Oral prednisone (or equivalent) monotherapy: i. Must be stable (including prednisone or equivalent = 0 mg\u002Fday) for \\> 2 weeks before 1st anifrolumab infusion.\n\n     ii. Maximum daily dose: ≤ 40 mg\u002Fday. b) Antimalarials and\u002For immunosuppressant(s) with or without GC: i. Permitted medications include: antimalarials, azathioprine, mycophenolate mofetil\u002Fmycophenolic acid, methotrexate, mizoribine, tacrolimus, and cyclosporine (Note: The combination of azathioprine and methotrexate is not allowed due to known safety issues. The combinations of tacrolimus\u002Fcyclosporine with other immunosuppressants above should be avoided. Combination with antimalarials is allowed.).\n\n     ii. Start date: ≥ 12 weeks prior to signing the ICF. iii. Must be stable ≥ 8 weeks prior to signing the ICF. iv. The daily dose should follow the medical practice and not exceed the maximum allowed daily dose: v. Azathioprine: ≤ 200 mg\u002Fday. vi. Mycophenolate mofetil ≤ 2 g\u002Fday or mycophenolic acid ≤ 1.44 g\u002Fday. vii. Oral, subcutaneous (SC), or intramuscular methotrexate ≤ 25 mg\u002Fweek. viii. Mizoribine ≤ 150 mg\u002Fday. ix. Tacrolimus ≤ 0.2 mg\u002Fkg\u002Fday or cyclosporine ≤ 5 mg\u002Fkg\u002Fday, monitoring of serum concentration may be performed at the discretion of Investigator where practice guidelines mandate or in case of safety concerns.\n\n     c) Oral prednisone (or equivalent) plus immunosuppressant(s): i. Start dates for GC and immunosuppressants must be met. ii. Stability requirements for each medication must be met. iii. No minimum daily dose for GC when in combination with immunosuppressants. iv. Maximum daily dosages for each medication in (a) and (b) must not be exceeded.\n  8. Chest x-ray (obtained during Screening or within 12 weeks prior to signing of the ICF) or a computed tomography (CT) scan of the chest (within 12 weeks of signing the informed consent) which meets all the following:\n\n     1. No evidence of current active infection (e.g., pneumonia, tuberculosis \\[TB\\]) or previous TB; and\n     2. No evidence of malignancy; and\n     3. No clinically significant abnormalities (unless due to SLE).\n  9. TB Testing for Inclusion in the study: the participant must undergo an IGRA (e.g., QuantiFERON-Tuberculosis Gold \\[QFT G test\\]) test for TB obtained from the study central laboratory at Screening with any of the following results:\n\n     Negative test result Positive test result: referral to a TB specialist for evaluation and for which active TB has been ruled out (as described in the protocol definition), and initiation of treatment for latent TB prior to the first administration of study intervention in accordance with local SoC.\n\n     Indeterminate test result confirmed by repeat test using the same assay o The participant must be referred to a TB specialist for evaluation (with assessment and treatment recommendation comprehensively documented in source) and initiation of appropriate latent TB treatment, if warranted, prior to the first administration of study intervention. If no latent TB treatment is warranted, the participant may enter the study without latent TB treatment but must be retested at least every 12 months. If the retest result is indeterminate or negative, the participant may continue in the study with routine testing.\n\n     o If, upon retest, the result is indeterminate, the participant may continue in the study without treatment. The participant will continue routine TB testing as outlined in the SoA (Section 1.3).\n\n     Weight\n  10. Body weight ≥ 40 kg. Sex\n  11. Female participants:\n\n      a) Negative serum β-hCG test at Screening (females of childbearing potential only).\n\n      b) Women of childbearing potential must have a negative urine pregnancy test at Week0(Day 1), prior to administration of study intervention.\n\n      c) Women of non-childbearing potential must be postmenopausal or have been surgically sterilized (for example: bilateral oophorectomy, bilateral salpingectomy, or complete hysterectomy), which should be documented in the participant's medical records. The following age-specific requirements may apply for a postmenopausal state: i. Women who were taking HRT (Hormone Replacement Therapy):\n\n  \u003C!-- -->\n\n  1. Women \\\u003C 50 years old will be considered postmenopausal if they have been amenorrhoeic for ≥ 12 months following cessation of HRT and the FSH level in a sample collected during Screening is in the laboratory's normal range for postmenopausal women. Until FSH is documented to be within menopausal range, the patient should be considered as a WOCBP.\n  2. Women ≥ 50 years old will be considered postmenopausal if they have been amenorrhoeic for ≥12 months following cessation of all HRT.\n\nii. Women who were not taking HRT:\n\n1. Women \\\u003C 60 years old will be considered postmenopausal by a history of ≥ 12 months of amenorrhea and if the FSH level in a sample collected during Screening is in the laboratory's normal range for postmenopausal women.\n2. Women ≥ 60 years old will be considered postmenopausal if they have been amenorrhoeic for ≥ 12 months prior to the Week 0(Day 1)without an alternative medical cause.\n\niii. If the above criteria are not met, the patient should be regarded as a WOCBP.\n\n12\\. Contraceptive methods should be used in all sexually active men and women. Highly effective methods include oral contraceptives, contraceptive implants, intrauterine device, condoms and vasectomy. Female participants must not get pregnant, donate eggs or breastfeed a child during the study and up to 16 weeks after the last dose of the study medication.\n\n13\\. Male participants must not donate sperm during the study and for 16 weeks after the last dose of the IMP.\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  1. History of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome Vasculitis due to SLE is allowed in the study.\n  2. Non-SLE diseases that potentially require systemic glucocorticoids (e.g. IV or oral), as determined by medical judgment, e.g. asthma, chronic obstructive pulmonary disease (COPD).\n  3. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, in the opinion of primary investigator or AstraZeneca, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.\n  4. Active severe SLE-driven renal disease where, in the opinion of the primary investigator or AstraZeneca, protocol-specified standard therapy is insufficient and utilisation of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.\n  5. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease are excluded. Subjects with an overlap syndrome of SLE with rheumatoid arthritis are not excluded as long as they meet the criteria for the classification of SLE.\n  6. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.) are excluded. Subjects with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.\n  7. History of, or current diagnosis of, catastrophic anti-phospholipid syndrome (APS) within one year prior to signing the ICF. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism are excluded. Subjects with a history of 3 or more unexplained consecutive pregnancy losses would also be excluded. Participants with other degrees of APS adequately controlled by anticoagulants ((i.e., if on warfarin, an international normalized ratio \\[INR\\] target 2 to 3 or as appropriate for the clinical situation) or aspirin for at least 12 weeks can be recruited to the study.\n  8. Current or history of Hypothalamic-Pituitary-Adrenal (HPA) axis related disease, Addison disease, adrenal haemorrhage etc.\n  9. Current infections requiring hospitalisation.\n  10. History of recurrent infection requiring hospitalisation and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).\n  11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening:\n\n      a) An HIV test must be performed during Screening, and the result should be available prior to Week 0 (Day 1). The participant is ineligible to participate in the study when positive for HIV antibody or infection (i.e., positive nucleic acid test) performed by the central laboratory. Participants refusing HIV testing during the Screening Period will not be eligible for study participation.\n  12. Severe herpes zoster or recurrent herpes zoster:\n\n      1. Any severe case, as defined by study guidelines, of herpes zoster infection at any time prior to Week 0 (Day 1), including, but not limited to, non-cutaneous herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes involving the retina (ever).\n      2. Any herpes zoster infection that has not completely resolved within 12 weeks prior to signing the ICF.\n  13. Confirmed positive test for hepatitis B serology for:\n\n      1. Hepatitis B surface antigen (HBsAg), OR\n      2. Hepatitis B core antibody (HBcAb) AND hepatitis B virus (HBV) DNA detected above the lower limit of quantitation (LLOQ) by reflex testing by the central laboratory at screening.\n\n      Note: Participants who are HBcAb positive at screening will be tested at least every 12 months for HBV DNA. To remain eligible for the study, the participant's HBV DNA levels must remain below the LLOQ as per the central laboratory.\n  14. Active hepatitis C infection (defined as positive hepatitis C virus \\[HCV\\] antibody and detectable HCV ribonucleic acid (RNA) as confirmed by central laboratory.\n  15. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.\n  16. Active tuberculosis (TB):\n\n      1. Medical history or signs or symptoms of active TB prior to or during Screening.\n      2. A chest x-ray during the Screening Period or within 12 weeks prior to signing of the ICF with evidence of active or signs of prior TB infection\n      3. Recent contact with a person with active TB OR if there has been such contact, referral to a physician specializing in TB to undergo additional evaluation prior to Week 0 (Day 1) (documented comprehensively in source), and, if warranted, receipt of appropriate treatment for latent TB at or before the first administration of study intervention\n  17. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).\n  18. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).\n  19. Current or previous history of malignancies, apart from:\n\n      1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥3 months prior to Week 0 (Day 1).\n      2. Cervical cancer in situ treated with apparent success with curative therapy ≥1 year prior to Week 0 (Day 1).\n  20. Females with abnormal cervical cancer screening results Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening (Pap smear or human papilloma virus \\[HPV\\] tests as per local guidelines) with a normal test result within 2 years prior to Week 0 (Day 1). Any abnormal cervical cancer screening result documented within 2 years prior to Week 0 (Day 1) must be repeated to confirm participant eligibility.\n\n      Note: Females aged \\\u003C 25 years, who have never been sexually active or have well-documented HPV vaccination records may not, at the investigator's discretion, require a cervical cancer screening test.\n  21. Any history of an anaphylactic reaction to human proteins or monoclonal antibodies.\n\n      Prior\u002FConcomitant Therapy\n  22. Prior receipt of anifrolumab.\n  23. Current receipt of other biologics or small molecule targeted treatments.\n  24. Currently participating in an interventional clinical trial with an IMP.\n  25. Participants with receipt of\u002Fuse of any live or attenuated vaccine within 8 weeks prior to signing the ICF will be excluded from the study. Use of any live or attenuated vaccine is not allowed during the study up until study completion or at least 12 weeks after the last study dose.\n  26. Receipt of any prohibited medication listed in Appendix H.\n  27. Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.\n\n      Diagnostic Assessments\n  28. At Screening (within 4 weeks before Week 0), any of the following (note: retesting of laboratory test results during Screening may be repeated once):\n\n      1. Serum creatinine \\> 2.0 mg\u002FdL (or \\> 181 μmol\u002FL)\n      2. Urine protein\u002Fcreatinine ratio \\> 2.0 mg\u002Fmg (or \\> 226.30 mg\u002Fmmol)\n      3. Aspartate aminotransferase (AST) \\> 2.0 × upper limit of normal (ULN)\n      4. Alanine aminotransferase (ALT) \\> 2.0 × ULN\n      5. TBL \\> ULN (unless due to Gilbert's syndrome)\n      6. Neutrophil count \\\u003C 1000\u002FμL (or \\\u003C 1.0 × 109\u002FL)\n      7. Hb \\\u003C 8 g\u002FdL (or \\\u003C 80 g\u002FL), or \\\u003C 7 g\u002FdL (or \\\u003C 70 g\u002FL) related to participant's SLE such as in active haemolytic anaemia\n      8. Glycosylated haemoglobin (HbA1c) \\> 8% (or \\> 0.08) at Screening (in diabetic participants only) Others\n  29. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.\n  30. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.\n  31. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period .\n  32. Any condition that, in the opinion of the investigator or AstraZeneca, would interfere with treatment outcomes of the study intervention or put participant at safety risk.",{"count":120,"type":22},417,[122],"PHASE3","This study aims to describe clinical outcomes, with focus on remission, achieved with use of anifrolumab participants with SLE on standard-of-care (as recommended by 2025 China SLE guidelines). Further, it aims to describe outcomes alongside a systematic approach to glucocorticoid (GC) tapering, in terms of effectively minimising GC use, as well as discontinuing GC use, thereby reducing GC exposure.",[29],"NOT_YET_RECRUITING","2026-08-03",{"date":64,"type":40},{"date":129,"type":22},"2026-09-04",{"date":131,"type":22},"2028-08-25",{"name":46,"class":47},44,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100626658","phase-3-a-study-of-nipocalimab-in-adults-with-moderate-to-severe-systemic-lupus-erythematosus-100626658","NCT07438496","A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","GARDENIA-SLE","Inclusion Criteria:-\n\n* Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening\n* Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\\>=) 24 weeks prior to screening and meeting european league against rheumatism\u002Famerican college of rheumatology (EULAR\u002FACR) classification criteria\n* Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \\>= 6 and a clinical SLEDAI-2K \\>= 4 at screening, AND a clinical SLEDAI-2K score \\>= 4 points at Week 0. For eligibility, points attributed to \"lupus headache,\" \"alopecia,\" and \"organic brain syndrome\" are excluded\n* Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization\n* Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening\n\nExclusion Criteria:\n\n* History of severe, progressive and\u002For uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and\u002For any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory\n* Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications\n* Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins\n* Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation",{"count":143,"type":22},600,[122],"The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).",[29],"2026-07-30",{"date":149,"type":40},"2026-07-31",{"date":151,"type":40},"2026-03-05",{"date":153,"type":22},"2031-11-07",{"name":155,"class":47},"Janssen Research & Development, LLC",231,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":110},"100608405","phase-3-a-research-trial-to-assess-if-cenerimod-is-efficacious-and-safe-to-treat-active-lupus-nephritis-on-top-of-regular-treatment-100608405","NCT07201129","A Research Trial to Assess if Cenerimod is Efficacious and Safe to Treat Active Lupus Nephritis on Top of Regular Treatment","A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy","LUMIOS","Main Inclusion Criteria:\n\n* Classification of systemic lupus erythematosus (SLE) made according to the 2019 European Alliance of Associations for Rheumatology \u002F American College of Rheumatology (EULAR\u002FACR) criteria.\n* Renal biopsy within 6 months prior to Screening visit indicating Class III or IV active glomerulonephritis with or without co-existing Class V, OR pure Class V membranous LN. If no biopsy was performed within 6 months of Screening, a biopsy will be performed during the Screening period, after all other inclusion\u002Fexclusion criteria are verified.\n* Active renal disease defined as urine protein\u002Fcreatinine ratio ≥ 1 mg\u002Fmg, assessed on a 24h urine collection.\n* eGFR ≥ 15 mL\u002Fmin\u002F1.73 m\\^2. Enrollment of participants with eGFR between ≥ 15 and \\\u003C 30 mL\u002Fmin\u002F1.73 m\\^2 requires:\n\n  * a renal biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli,\n  * activity index ≥ 2, and chronicity index \\\u003C 4, on the National Institutes for Health 2018 activity and chronicity indices. These indices must be assessed on the kidney biopsy dated less than 6 months prior to Screening and confirmed by a nephropathologist.\n* Initiation of the induction therapy with the mandatory following background therapy:\n\n  1. Mycophenolate mofetil 1-3 g\u002Fday orally or mycophenolate sodium 720-2160 mg\u002Fday orally at Randomization. This treatment can be in place before Screening or started at Screening.\n  2. Corticosteroids: 1-3 intravenous (i.v.) pulses of methylprednisolone at 250 to 1000 mg\u002Fpulse\u002Fday (maximum cumulative 3000 mg) followed by oral prednisone (or equivalent) at 0.5 mg\u002Fkg\u002Fday with a cap at 40 mg\u002Fday. Pulses can be administered during screening and up to 2 weeks prior to screening. Participants who cannot take the pulse i.v. corticosteroid therapy should directly start on 0.8-1.0 mg\u002Fkg\u002Fday (max 80 mg\u002Fday) oral prednisone (or equivalent), within the same window as i.v. pulses.\n\nNote: If treatment with an antimalarial or belimumab is taken, it must be initiated at least 4 weeks prior to Screening and must be at stable dose during these 28 days prior to Randomization and continued at a stable dose until End-of-Treatment. Participants on azathioprine must be switched to mycophenolate mofetil or mycophenolate sodium prior to Randomization.\n\n* Participants of childbearing potential must agree to:\n\n  * Use a highly effective method of contraception from the Screening visit up to at least 24 weeks after discontinuation of trial intervention.\n  * Undertake monthly urine pregnancy tests during the trial and up to at least 24 weeks after discontinuation of trial intervention.\n\nMain Exclusion Criteria:\n\n* Severe active central nervous system lupus\n* History of, or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with the LN assessment and confound the disease activity assessment (e.g., diabetic nephropathy), or require dialysis, transplantation or end-stage renal disease.\n* History or presence of Mobitz type II or third-degree atrioventricular block, sick sinus syndrome, symptomatic bradycardia, or syncope associated with cardiac disorders.\n* Participants who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, vascular thrombosis, decompensated heart failure requiring hospitalization, or heart failure defined by the New York Heart Association Class III\u002FIV within 6 months prior to Screening.\n* Resting heart rate \\\u003C 50 bpm as measured by the 12-lead electrocardiogram (ECG) at Screening or at Randomization.\n* Diagnosis of active or latent tuberculosis at Screening or within 6 months prior to Screening\n* Negative antibody test for varicella-zoster virus\n* Positive results for serological markers for hepatitis A, B, C and E indicating acute or chronic infection\n* Participants with a positive human immunodeficiency virus (HIV) test or who have any other congenital or acquired immunodeficiency\n* Presence of any of the following abnormalities, detected during the ophthalmological evaluation and\u002For by optical coherence tomography, as evaluated by the site ophthalmologist, during Screening:\n\n  * Macular edema of any cause: diabetic, cystoid, tractional.\n  * Foveal degeneration: macular hole, macular pseudohole, hereditary or degenerative maculopathies.\n  * Active uveitis, papilledema.\n  * Retinal neovascularization of any cause and in any location.\n* Significant hematology abnormality at Screening:\n\n  * Hemoglobin \\\u003C 7 g\u002FdL;\n  * Lymphocyte count \\\u003C 500 \u002FμL (0.5 × 10\\^9\u002FL);\n  * White blood cell count \\\u003C 1500\u002FμL (1.5 × 10\\^9\u002FL) or\n  * Platelets \\\u003C 25,000\u002FμL (25 × 10\\^9\u002FL)\n* Treatment with the following medications within 5 half-lives of the medication prior to Randomization: Cyclosporine, voclosporin, tacrolimus, sirolimus, cyclophosphamide.\n* Treatment with the following medications within 90 days prior to Randomization:\n\n  * Leflunomide.\n  * i.v. immunoglobulins.\n  * Methotrexate.\n  * Tyrosine kinase inhibitors.\n* Treatment with anifrolumab within 6 months prior to Randomization.\n* Treatment with biological immunosuppressive agents, (e.g., anti-tumor necrosis factor \\[anti-TNF\\], anti-interleukin-1 \\[anti-IL1\\], anti-IL6 therapies) within 90 days prior to Randomization.\n* Treatment with B cell-depleting biological agents (e.g., rituximab, obinutuzumab or ocrelizumab) within 12 months prior to Randomization.\n* Treatment with any of the following medications any time prior to Screening:\n\n  * Alemtuzumab.\n  * Sphingosine-1-phosphate receptor modulators (e.g., fingolimod).\n  * Participants previously randomized to cenerimod or placebo in any trial involving cenerimod.\n* Pregnancy confirmed via a serum pregnancy test at the Screening visit or a urine\u002Fserum pregnancy test at the Randomization visit or planning to become pregnant, or lactating participant.",{"count":166,"type":22},300,[122],"The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are:\n\n* Does cenerimod improve kidney function in participants?\n* What medical problems do participants have when taking cenerimod?\n\nResearchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment.\n\nParticipants will:\n\n* Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment.\n* Visit the clinic every 1 to 3 months for checkups and tests.",[170,29],"Nephritis, Lupus","2026-07-29",{"date":147,"type":40},{"date":174,"type":40},"2026-02-09",{"date":176,"type":22},"2030-02",{"name":178,"class":47},"Viatris Innovation GmbH",{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100618332","achievement-of-lldas5-in-patients-with-systemic-lupus-erythematosus-treated-with-anifrolumab-100618332","NCT07330245","Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.","DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy","DAHLIA","Inclusion Criteria:\n\n* Provided informed consent to participate in the study;\n* Aged 18 years or older;\n* Fulfilled the 2019 EULAR\u002FACR classification criteria for SLE at the time of study entry;\n* Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;\n\nExclusion Criteria:\n\n* Patients who are at LLDAS5 at the time of study entry;\n* Previous exposure to anifrolumab;\n* Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy \\[mycophenolate mofetil (MMF)\u002Fcyclophosphamide (CYC) + high dose steroids\\], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus\n* Currently participating in any interventional clinical trial with an investigational product;\n* Inability to understand and sign the informed consent and to fill in patient questionnaires",{"count":188,"type":22},218,"OBSERVATIONAL","This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5",[29],[193,194],"Lupus Erythematosus, Systemic.","Anifrolumab.","2026-07-21",{"date":197,"type":40},"2026-07-22",{"date":199,"type":40},"2025-12-31",{"date":201,"type":22},"2028-09-30",{"name":46,"class":47},22,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":212,"sex":213,"minAge":18,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":4},"100623189","omega-3-supplementation-in-systemic-lupus-erythematosus-100623189","NCT07393399","Omega-3 Supplementation in Systemic Lupus Erythematosus","Omega-3 Supplementation in Women With Systemic Lupus Erythematosus: Protocol for a Randomized, Double-blind, Placebo-controlled Trial","SLE-OMEGA","Inclusion Criteria:\n\n* Women aged 18 to 45 years\n* Diagnosis of systemic lupus erythematosus (SLE) according to the EULAR\u002FACR classification criteria\n* Remission or low disease activity, defined as SLEDAI-2K ≤ 4\n* On stable doses of hydroxychloroquine and\u002For glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent) for at least 8 weeks prior to enrollment\n* Ability and willingness to provide written informed consent\n* Willingness to maintain usual dietary patterns and physical activity levels throughout the study period\n\nExclusion Criteria:\n\n* Current use of omega-3 fatty acid supplements or use within the previous 3 months\n* Pregnancy or lactation\n* Presence of severe infection, neoplastic disease, or diabetes mellitus\n* Known allergy or intolerance to fish oil or soybean oil\n* Any medical condition or circumstance that, in the investigator's opinion, could interfere with study participation or adherence to the protocol",true,"FEMALE","45 Years",{"count":80,"type":22},[217],"NA","This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether oral omega-3 fatty acid supplementation can modulate inflammation, oxidative stress, and telomere maintenance in women with systemic lupus erythematosus (SLE) in remission. Women aged 18-45 years with SLE (SLEDAI-2K ≤ 4) will be allocated to receive either omega-3 (5,400 mg\u002Fday of EPA+DHA) or placebo for 12 weeks. A parallel healthy control group will undergo the same intervention scheme. Clinical, biochemical, and molecular assessments including inflammatory cytokines, oxidative stress markers (TBARS, ORAC, T-AOC), and relative telomere length (T\u002FS ratio) will be conducted at baseline and post-intervention. The trial is designed to determine whether omega-3 can attenuate chronic low-grade inflammation and oxidative imbalance, both key drivers of cellular dysfunction and premature immunosenescence in SLE. Omega-3 PUFAs exert anti-inflammatory effects through competition with arachidonic acid for COX\u002FLOX enzymes and by activating GPR120, which inhibits the TAK1-NF-κB-JNK inflammatory cascade. Their antioxidant effects may further reduce reactive oxygen species and support genomic stability. By integrating clinical, biochemical, and molecular outcomes, this study provides a comprehensive evaluation of omega-3 effects on pathways implicated in accelerated cellular aging in autoimmune diseases. The findings are expected to clarify whether omega-3 supplementation represents a safe, low-cost strategy capable of improving inflammatory and oxidative profiles and contributing to telomere preservation in women with SLE, supporting future precision-nutrition approaches in this population.",[29],"2026-07-15",{"date":222,"type":40},"2026-07-17",{"date":224,"type":22},"2026-07",{"date":226,"type":22},"2028-07",{"name":228,"class":229},"University of Sao Paulo","OTHER",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100625563","nis-to-examine-disease-activity-in-sle-patients-treated-with-subcutaneous-anifrolumab-in-routine-care-100625563","NCT07424261","NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care","Effectiveness of Subcutaneous Anifrolumab in Systemic Lupus Erythematodes - A Non-interventional, Prospective, Multicenter Study on Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care","VIOLET","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the informed consent\n* Diagnosis of SLE\n* Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)\n* Prescription of anifrolumab SC was decided prior to and independently of the study\n* Signed and dated written informed consent prior to enrolment into the study\n* Willing and able to participate in all study evaluations and procedures\n\nExclusion Criteria:\n\n* Prior exposure to anifrolumab\n* Treatment with concurrent biologics\n* Current or planned participation in a clinical study that does not constitute routine care\n* Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \\[MMF\\]\u002Fcyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin\u002Fjoint involvement), or active severe or unstable neuropsychiatric lupus\n* Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits)\n* Pregnancy or breast feeding at study enrolment","130 Years",{"count":240,"type":22},125,"VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before.",[29],[244,245,246,247,248],"anifrolumab subcutaneous","real-world evidence","remission","fatigue","patient-reported quality of life","2026-06-23",{"date":251,"type":40},"2026-06-24",{"date":253,"type":40},"2026-03-19",{"date":255,"type":22},"2029-08-31",{"name":46,"class":47},16,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100641214","phase-1-cd19-directed-car-t-cell-therapy-in-refractory-systemic-lupus-erythematosus-100641214","NCT07659704","CD19-Directed CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus","CD19-targeted Lymphocyte Engineering Validation for the trEatment of Refractory Systemic Lupus Erythematosus","CLEVER-SLE","Inclusion Criteria:\n\n* Adults aged 18 to 50 years, inclusive.\n* Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 ACR\u002FEULAR classification criteria.\n* Active disease at screening, defined as SLEDAI-2K ≥4 and Physician Global Assessment (PGA) ≥0.5.\n* Inadequate response, intolerance, or contraindication to corticosteroids and at least two of the following therapies: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, belimumab, rituximab, or tacrolimus.\n* Adequate organ function, including:\n\n  * Hepatic function: AST and ALT ≤3× upper limit of normal (ULN); total bilirubin ≤2× ULN (participants with documented Gilbert syndrome are eligible).\n  * Hematologic function: neutrophils ≥1,000\u002Fmm³; hemoglobin ≥8 g\u002FdL without transfusion within 14 days; lymphocytes ≥500\u002Fmm³; platelets ≥20,000\u002Fmm³ without transfusion within 14 days.\n  * Renal function: estimated creatinine clearance ≥30 mL\u002Fmin (CKD-EPI).\n  * Cardiac function: left ventricular ejection fraction ≥40%.\n  * Pulmonary function: oxygen saturation ≥92% on room air.\n* Women of childbearing potential must agree to use highly effective contraception during study participation and for 12 months after CAR-T cell infusion.\n* Male participants must agree to use barrier contraception during study participation and for 12 months after CAR-T cell infusion.\n* Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe pulmonary hypertension (estimated pulmonary artery systolic pressure \\>50 mmHg).\n* Requirement for systemic anticoagulation at screening.\n* Clinically significant cardiovascular disease, including NYHA Class III\u002FIV heart failure, myocardial infarction, unstable arrhythmias, or unstable angina within the previous 6 months.\n* Active neurological disease (stroke, epilepsy, or neurodegenerative disorders) within the previous 12 months.\n* History of malignancy within 2 years prior to screening, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, or stage I uterine cancer.\n* Previous or suspected hemophagocytic lymphohistiocytosis\u002Fmacrophage activation syndrome.\n* Active or uncontrolled bacterial, viral, fungal, or other infection.\n* Active hepatitis B infection or detectable HBV DNA.\n* Active hepatitis C infection or detectable HCV RNA.\n* Human immunodeficiency virus (HIV) infection.\n* Pregnancy, breastfeeding, or plans to become pregnant during the study or within 12 months after CAR-T cell infusion.\n* Major surgery within 4 weeks prior to screening.\n* Administration of a live attenuated vaccine within 4 weeks prior to screening.\n* Prior allogeneic or autologous hematopoietic stem cell transplantation or prior solid organ transplantation.\n* Inability or unwillingness to comply with study procedures and follow-up requirements.\n* Any medical condition that, in the investigator's judgment, could compromise participant safety or interfere with study assessments.","50 Years",{"count":257,"type":22},[25,26],"Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks the body's own tissues and organs. The disease can affect the skin, joints, kidneys, blood cells, brain, and other organs, leading to significant health problems and reduced quality of life. Although several treatments are available, some patients continue to have active disease despite receiving standard therapies.\n\nRecent research has shown that B cells, a type of immune cell, play a central role in the development and persistence of SLE. CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy is an innovative treatment that uses a patient's own immune cells, genetically modified to recognize and eliminate B cells. This approach has already shown remarkable success in certain blood cancers and has recently produced encouraging results in patients with severe autoimmune diseases, including SLE.\n\nThe CLEVER-SLE study is a Phase I\u002FII clinical trial designed to evaluate the safety and potential effectiveness of CD19-directed CAR-T cell therapy produced at Ribeirao Preto Blood Bank in patients with SLE who have not responded adequately to conventional treatments. Participants will undergo the collection of their own immune cells, which will be modified in a specialized laboratory to produce CAR-T cells. After receiving preparatory chemotherapy, participants will receive a single intravenous infusion of these CAR-T cells.\n\nThe main goal of this study is to evaluate the safety of this treatment. Researchers will also assess its effects on disease activity, symptoms, organ involvement, medication requirements, immune system markers, and the duration of clinical responses. The study aims to determine whether CD19-directed CAR-T cell therapy can provide a new treatment option for patients with refractory SLE and contribute to the development of CAR-T therapies for autoimmune diseases.",[29],[33,32,272,35,273,274,92,275,276,277,278,279,280,281,282],"Refractory Systemic Lupus Erythematosus","CAR-T Cell Therapy","CD19-Directed CAR-T Cells","Chimeric Antigen Receptor T Cells","B Cell Depletion","B Lymphocytes","Autoimmune Diseases","Cellular Therapy","Advanced Therapy Medicinal Products","Immune Reconstitution","Autologous CAR-T Cells","2026-06-15",{"date":285,"type":40},"2026-06-22",{"date":287,"type":22},"2026-10-01",{"date":289,"type":22},"2028-10-01",{"name":228,"class":229},2,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":71},"100327492","phase-4-trial-of-belimumab-in-early-lupus-100327492","NCT03543839","Trial of Belimumab in Early Lupus","Pilot Trial of Belimumab in Early Lupus","Inclusion Criteria:\n\n* Diagnosis of SLE per current ACR classification criteria\n* Date of SLE diagnosis within 2 years of screening\n* ANA positive (with a titer ≥ 80)\n* anti-ds DNA antibody positive\n* Mild to moderate disease activity define by a SLEDAI-2K ≥4\n* Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg\u002Fday.\n* If on methotrexate, dose must be stable for 4 weeks\n* Concomitant treatment with hydroxychloroquine unless documented inability to tolerate\n* Able and willing to give written informed consent and comply with the requirements of the study protocol\n* Negative serum pregnancy test (for women of child bearing potential)\n* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment\n\nExclusion Criteria:\n\n* Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.\n* Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.\n* Active renal or nervous system disease or disease activity fulfilling BILAG A criteria\n* Use of high dose steroids (\\>0.5 mg\u002Fkg\u002F day) within the 4 weeks prior to screening\n* Expectation (by the investigator) that the subject will require treatment with a disease modifying drug within the first 52 weeks of the study\n* Hemoglobin: \\\u003C 8.0 gm\u002FdL\n* Platelets: \\\u003C 50,000\u002Fmm\n* ANC \\\u003C 1.0 x 103\u002Fmm\n* AST or ALT \\>2.5 x Upper Limit of Normal unless related to primary disease.\n* Creatinine clearance ≤ 25ml\u002Fmin per 1.73 m2\n* Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B core Ab or Hepatitis C antibody)\n* History of positive HIV (HIV conducted during screening if applicable)\n* Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)\n* Receipt of a live vaccine within 30 days prior to baseline or concurrently with belimumab\n* Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies\n* Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)\n* Hospitalization for treatment of infection within 60 days of Day 0.\n* Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0\n* History of serious recurrent or chronic infection\n* Lack of peripheral venous access\n* History of drug, alcohol, or chemical abuse within 365 days prior to Day 0\n* Pregnancy (a negative serum pregnancy test must be obtained for all women of childbearing potential at screening; a urine pregnancy test must be negative \\\u003C 7 days prior to first dose and monthly)\n* Lactation\n* History of psychiatric disorder that would interfere with normal participation in this protocol\n* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications\n* History of malignant neoplasm within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n* Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and\u002For any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk\n* History of a primary immunodeficiency\n* Have a significant IgG deficiency (IgG level \\\u003C 400 mg\u002FdL)\n* Have an IgA deficiency (IgA level \\\u003C 10 mg\u002FdL)\n* Have any other clinically significant abnormal laboratory value in the opinion of the investigator\n* Comorbidities requiring corticosteroid therapy, including those which have required two or more courses of systemic courses of systemic corticosteroids within the previous 12 months\n* Inability to comply with study and follow-up procedures",{"count":300,"type":22},30,[302],"PHASE4","This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.",[29,305],"Lupus Erythematosus",[307,308,309,310],"lupus","early lupus","belimumab","autoreactivity","2026-06-10",{"date":313,"type":40},"2026-06-12",{"date":315,"type":40},"2020-09-15",{"date":317,"type":22},"2029-03",{"name":319,"class":229},"Northwell Health",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100560749","phase-2-a-study-of-rapcabtagene-autoleucel-in-active-refractory-systemic-lupus-erythematosus-sle-or-lupus-nephritis-ln-patients-autograph---sleln-100560749","NCT06581198","A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE\u002FLN)","A Phase 2, Open-label, Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel in Patients With Active, Refractory Systemic Lupus Erythematosus (SLE) or Active, Refractory Lupus Nephritis (LN).","Key Inclusion Criteria:\n\n* Men and women with SLE, aged \\>= 18 years and =\\\u003C 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE at screening.\n* Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of \\>= 1:80 (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.\n* Active lupus nephritis without signs of significant chronicity or active systemic lupus erythematosus\n* SLEDAI-2K Criteria at screening: SLEDAI-2K score \\>= 6 points (Gladman et al 2002, Touma et al 2011), excluding points attributed to \"fever\", \"lupus headache\", \"alopecia\", and \"organic brain syndrome\".\n* Inadequate response at screening to at least two therapies\n\nKey Exclusion Criteria:\n\n* Any acute, severe lupus related-flare at screening that needs immediate treatment other than pulse GCs and\u002For makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy\n* Inadequate organ function during screening and prior to randomization\n* History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants prior to randomization\n* Human immunodeficiency virus (HIV) positivity at screening.\n* Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV) at screening.\n* Grade 2 or higher thromboembolic event in the past 4 weeks prior to screening.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":328,"type":22},179,[26],"The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).",[29,35],[333,334,335,336],"Chimeric Antigen Receptor-T (CAR-T)","rapcabtagene autoleucel","Lupus Nephritis (LN)","Systemic Lupus Erythematosus (SLE)","2026-06-02",{"date":339,"type":40},"2026-06-03",{"date":341,"type":40},"2024-09-04",{"date":343,"type":22},"2032-02-06",{"name":345,"class":47},"Novartis Pharmaceuticals",101,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":354,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":363,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":71},"100592874","teams-engaged-in-accessible-mental-health-interventions-for-lupus-erythematosus-and-dermatomyositis-stress-100592874","NCT06999109","Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress","TEAM-LEADS","Inclusion Criteria:\n\n* Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)\n* Age 13-22 years old at time of enrollment\n\nExclusion Criteria:\n\n* Inability to complete surveys\u002Finterviews reliably\n* Lack of access to internet-enabled device;\n* Non-JSLE\u002FJDM diagnosis\n* History of myocardial infarction or cerebrovascular accident\n* Evidence of severe emotional distress defined as any of the following at time of screening: a) Patient Health Questionnaire for Adolescents (PHQ9A) score ≥ 15 indicating severe depression; b) PHQ9A suicidality item score \\> 0 indicating presence of any suicidal ideation; c) any other evidence noted of severe emotional distress per PI's judgment.","13 Years","22 Years",{"count":7,"type":22},[217],"The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.",[34,360,361,305,29,362],"Dermatomyositis, Juvenile","Dermatomyositis","Lupus or SLE",[364,365,366,34,361,367,368,369,370,371,372,373,374,375,376],"Stress","Depression","Anxiety","Pediatric Rheumatology","Physical Activity","Diet Quality","Sleep","Cardiovascular Health","Health Behaviors","Remote Intervention","Online Intervention","Co-Design","Intervention Refinement","2026-05-22",{"date":379,"type":40},"2026-05-27",{"date":381,"type":22},"2027-02-01",{"date":383,"type":22},"2029-01-15",{"name":385,"class":229},"Duke University",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":400,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":71},"100532108","brief-pain-exposure-therapy-bpet-for-nociplastic-pain-100532108","NCT06208514","Brief Pain Exposure Therapy (BPET) For Nociplastic Pain","BPET","Inclusion Criteria:\n\n* Able to read, write and speak English\n* Internet access and audio-visual conferencing capability (e.g., Zoom meetings by phone or computer) in the home\n\nFibromyalgia participants must have:\n\n* Physician diagnosis of fibromyalgia\n* OR: meet 2016 American College of Rheumatology (ACR) Criteria for FM: Widespread pain index score is ≥ 7 and symptom severity scale score is ≥ 5, or widespread pain index score is 4 to 6 and symptom severity score is ≥ 9\n* OR: have pain self-reported in 4 out of 7 body regions in the General Sensory Sensitivity (GSS)-brief body map AND Opioid Use Disorder diagnosis by a physician.\n\nLupus participants must have:\n\n* Physician diagnosis of systemic lupus erythematosus\n* AND: Have pain self-reported in 4 out of 7 body regions in the GSS-brief body map\n* AND: No change in medications or steroid dose for one month prior to entry (to avoid oscillation of steroid dosing during the study due to active disease).\n\nChronic Low Back Pain participants must have:\n\n* Low Back Pain for at least half the days over the past 6 months\n* Over the past 7 days, an average pain intensity of at least 4 out of 10\n\nExclusion Criteria:\n\n* Indication of a co-occurring (non-fibromyalgia OR non-lupus) cause of chronic pain (e.g., inflammatory arthritis, other autoimmune disorders, spinal cord injury, cancer)\n* Currently receiving cognitive-behavioral therapy or other psychological therapies for pain\n* Open litigation regarding chronic pain in the past 1 year, as assessed in preliminary study screening.\n* Inability to provide informed consent and complete study procedures (e.g., indications of suspected major cognitive impairment via observations of study staff during consenting) that would preclude comprehension or participation in study protocols.\n* Pregnant or breastfeeding\n* Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.\n* Lupus group only: taking \\>10 mg prednisone (or equivalent steroid) dose per day as an indicator of ongoing disease activity (with no other strict exclusions based on medications)\n* Chronic Pelvic Pain group only: surgery for any chronic pelvic pain related condition in the past 6 months\n* Chronic low back pain only: scheduled back surgery; leg pain that is greater than your back pain",{"count":240,"type":22},[217],"This study is intended to test whether a brief Zoom-based behavioral treatment can help adults with fibromyalgia (FM), Lupus, chronic pelvic pain, and chronic low back pain learn effective strategies for reducing pain, disability and other problems that can come with fibromyalgia, Lupus, chronic pelvic pain, and chronic low back pain (such as depression or anxiety).",[397,29,398,399],"Fibromyalgia","Chronic Pelvic Pain","Chronic Low Back Pain (CLBP)",[401,402],"Pain exposure therapy","Telehealth-based behavioral intervention","2026-05-06",{"date":405,"type":40},"2026-05-11",{"date":407,"type":40},"2024-03-04",{"date":409,"type":22},"2027-07",{"name":411,"class":229},"University of Michigan",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":430,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":71},"100583770","dose-response-of-exercise-for-arthritis-management-100583770","NCT06880653","Dose Response of Exercise for Arthritis Management","Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes","DREAM","Inclusion Criteria:\n\n* 18 years or older\n* Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have any contraindications to exercise (besides arthritis)\n* Engage in \\>45 min\u002Fweek of Actigraph assessed moderate to vigorous intensity activity\n* Are pregnant, breastfeeding, or planning to become pregnant in the next year\n* Are planning to relocate out of the Columbia, SC area in the next 12 months,\n* Do not have a device compatible with Fitbit\n* Have uncontrolled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg)\n* Plan to have a surgery that affects mobility in the next 12 months\n* Have a serious cognitive impairment.\n* Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes\u002Fweek).",{"count":421,"type":22},285,[217],"The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes\u002Fweek, 90 minutes\u002Fweek, or 150 minutes\u002Fweek) on arthritis symptoms.",[425,426,427,428,429,29],"Arthritis","Rheumatoid Arthritis (RA)","Gout","Fibromyalgia (FM)","Osteoarthritis",[431,432,433],"arthritis","exercise","physical activity","2026-04-02",{"date":436,"type":40},"2026-04-03",{"date":438,"type":40},"2025-03-28",{"date":440,"type":22},"2029-04-30",{"name":442,"class":229},"University of South Carolina",{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":17,"minAge":450,"maxAge":18,"enrollmentInfo":451,"targetDuration":4,"studyType":23,"phases":453,"briefSummary":454,"conditions":455,"keywords":458,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":71},"100619826","hypnotherapy-for-needle-related-procedural-pain-and-anxiety-management-in-a-pediatric-setting-100619826","NCT07349667","Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting","Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children aged 6 to 18 years\n* Scheduled for a painful medical procedure (injections or blood sampling)\n* Informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Children with a history of psychiatric disorders or cognitive impairment\n* Children unable to understand and participate in hypnotherapy sessions\n* Any contraindication to hypnotherapy\n* Children with diagnosed cancer","6 Years",{"count":452,"type":22},70,[217],"The proposed study aims to evaluate the effectiveness of hypnotherapy as a non-pharmacological intervention for managing pain and anxiety during needle-related medical procedures in children aged 5 to 17 years. This research addresses a significant gap in pediatric healthcare, where painful procedures often induce distress and long-term anxiety, leading to avoidance of necessary medical care. Conventional pain management strategies primarily rely on pharmacological methods, which may pose risks and side effects. Thus, exploring safe and effective alternatives, such as hypnotherapy, is crucial.The target group for this randomized controlled trial includes children scheduled for painful procedures, such as injections or blood sampling. Participants will be randomly assigned to either the hypnotherapy group, receiving tailored sessions conducted by trained hypnotherapists, or the standard of care group, which will involve conventional pain management techniques. The study will assess primary outcomes, including anxiety levels and pain perception, before, during, and after the procedures using validated scales.\n\nKey activities of the project include conducting individualized hypnotherapy sessions, monitoring anxiety and pain levels through structured assessments, and analyzing the data to determine the effectiveness and feasibility of hypnotherapy. Secondary objectives will explore potential long-term benefits and safety concerns associated with hypnotherapy. If successful, this study could significantly enhance pediatric pain management practices, reduce reliance on pharmacological interventions, and improve the overall healthcare experience for children. The findings may also inform broader healthcare policies regarding non-pharmacological pain management strategies in pediatric settings.",[456,457,29,360],"Arthritis, Juvenile","Arthritis, Juvenile Idiopathic",[459,460,461],"Hypnotherapy","pediatric","needle fear","2026-01-09",{"date":464,"type":40},"2026-01-20",{"date":466,"type":22},"2026-03",{"date":468,"type":22},"2029-12",{"name":470,"class":229},"Aarhus University Hospital",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":481,"conditions":482,"keywords":489,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":71},"100580823","effects-of-phytocannabinoids-on-immune-response-and-autophagy-during-chronic-immune-mediated-inflammatory-diseases-100580823","NCT06842316","Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases","In Vitro Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases","pCB-IMIDs","Inclusion Criteria:\n\n1. Male or female ≥ 18 years old\n2. Diagnosis confirmed by a rheumatologist of RA or spondyloarthropathy (with or without IBD) or psoriatic arthritis (with or without active psoriasis) or systemic lupus erythematosus or Sjögren's disease\n3. Patient who has expressed consent to participate in the study\n4. Patients affiliated to social security\n5. Treatments authorized as part of routine care: non-steroidal anti-inflammatory drugs (NSAIDs), level 1 to 3 analgesics, local corticosteroids, oral corticosteroid therapy (daily dose ≤15 mg\u002Fd), 5-aminosalicylic acid, salazopyrine, methotrexate, leflunomide, hydroxychloroquine, biotherapies and targeted therapies.\n\nExclusion Criteria:\n\n1. Patient who received intravenous corticosteroid therapy less than 4 weeks ago\n2. Patient receiving oral corticosteroid therapy with a daily dose \\>15 mg\u002Fday\n3. Consumption of CBD and\u002For recreational cannabis and\u002For positive saliva test for cannabis consumption and\u002For CBD\n4. Pregnant and lactating women\n5. Persons under guardianship or curatorship",{"count":480,"type":22},100,"Cannabis, in addition to its psychotropic properties, could have anti-inflammatory and immunomodulatory effects. Phytocannabinoids (pCBs) are a group of molecules naturally secreted by the cannabis plant. The major pCBs are cannabidiol (CBD) and Δ9-tetrahydrocannabinol Δ9 (THC). Only THC has psychotropic effects, which CBD does not have. Alongside these two main components, there is a wide variety of other molecules, such as other pCBs and terpenes which could increase the effects on immune system through synergistic interactions between these different compounds (\"entourage effect\").In vivo, pCBs essentially interfere with the endocannabinoid system, acting on many ubiquitous receptors, present on a significant number of different cell types. Numerous published studies show that pCBs have immunomodulatory and anti-inflammatory properties by acting on several of these receptors, whether through modulation of the immune response of different cell types, effects on cytokine networks, reduction of innate and adaptive responses and\u002For impact on cell survival or death (autophagy, proliferation\u002F apoptosis). The Immune-Mediated Inflammatory Diseases (IMIDs) affect 5 to 7% of the general population in Western countries, involve different organs (joints, skin, digestive tract) but share the same inflammatory mechanisms resulting from a dysregulation of the immune response. Our research focuses on the identification of the most effective phytochemical profile of pCBs, allowing an optimal effect on chronic inflammatory pathologies of interest among immune-mediated chronic inflammatory diseases (IMIDs). The pCB-IMIDs project is therefore part of an innovative translational project, around new therapeutic applications of medical cannabis (CannAppIMIDs). In our study, we will include 100 patients with one of IMIDs among Rheumatoid Arthritis, spondylarthritis, psoriatic arthritis, Sjogren disease and systemic lupus, at different stage and with different treatments. After patient's consent we will collect for research purposes an additional 40 ml of blood during a routine care blood test. Mononuclear and polynucleated blood cells will be exposed in vitro to different full-spectrum pCB extracts (full spectrum extract) including a CBD dominant and low THC extract (\\\u003C0.2%), 1 dominant THC extract, 1 balanced THC\u002FCBD extract and 1 dominant CBG extract. In this cross-sectional study, our objective will be to assess the biological effects of different pCB compositions on inflammatory profiles (concentrations of pro and anti-inflammatory cytokines and chemokines) and modulations of expression profiles (autophagy, apoptosis, and cannabinoid receptor expression profile).",[483,484,485,486,487,488,29],"Inflammatory Disorder of Immune System","Spondylitis, Ankylosing","Arthritis, Rheumatoid","Arthritis, Psoriatic","Inflammatory Bowel Diseases","Sjogren's Syndrome",[490,491,492,493],"IMIDs","phytocanabinoid","inflammatory effect","blood cells","2025-12-22",{"date":496,"type":40},"2025-12-30",{"date":498,"type":40},"2025-04-10",{"date":500,"type":22},"2027-04-09",{"name":502,"class":229},"Centre Hospitalier Régional d'Orléans",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":512,"studyType":189,"phases":4,"briefSummary":513,"conditions":514,"keywords":520,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":71},"100612090","interferon-signature-in-anti-ctla-4-and-anti-pd-1pd-l1-treated-cancer-patients-compared-with-systemic-autoimmune-disease-patients-100612090","NCT07249060","Interferon Signature in Anti-CTLA-4 and Anti-PD-1\u002FPD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients","Interferon Signature in Cancer Patients Treated With Anti-CTLA-4 and Anti-PD-1\u002FPD-L1 Therapies: A Multicenter, Prospective, Observational Cohort Study Comparing Cancer Patients and Non-Cancer Patients With Systemic Autoimmune Diseases","INTER-AUTENTIC","ICI cohort:\n\nInclusion Criteria:\n\n* Initiation of treatment with a single ICI or dual ICI therapy in accordance with current clinical guidelines;\n* Patients who are treatment-naïve to ICIs; and\n* Age ≥18 years.\n\nExclusion Criteria:\n\n* Estimated mortality of less than 3 months from the start of treatment;\n* Current combination therapy with chemotherapy, tyrosine kinase inhibitors, or other tumor-specific treatments;\n* Contraindication to treatment with ICIs (documented hypersensitivity, severe active autoimmune disease, Eastern Cooperative Oncology Group \\[ECOG\\] ≥3);\n* Ongoing immunosuppressive therapy, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n\nSAD cohort:\n\nInclusion Criteria:\n\n* Meeting classification criteria for Systemic Lupus Erythematosus (SLE) (ACR\u002FEULAR 2019), Primary Sjögren's Syndrome (pSS) (ACR\u002FEULAR 2016), Systemic Sclerosis (SSc) (ACR\u002FEULAR 2013), and\u002For Idiopathic Inflammatory Myopathy (IIM) (ACR\u002FEULAR 2017).\n* Age ≥18 years old.\n\nExclusion Criteria:\n\n* Estimated mortality less than 3 months from the start of follow-up.\n* Active immunosuppressive treatment, including prednisone at doses \\>10 mg\u002Fday or equivalent.\n* Recent diagnosis (\\\u003C1 year) of cancer, with the exception of non-melanoma skin cancer, or currently receiving active oncology-specific treatment.",{"count":166,"type":22},"48 Weeks","This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy. These side effects, known as immune-related adverse events (irAEs), occur when the immune system mistakenly attacks healthy tissues, like certain autoimmune diseases. At present, clinicians lack reliable tests to determine who is most likely to develop these reactions. The goal of this study is to determine whether substances in the blood called interferons (IFNs) could serve as early warning markers.\n\nThe study will include 300 people with cancer who are about to begin immunotherapy. To provide a meaningful comparison, the investigators will also enroll 40 individuals with autoimmune diseases such as lupus. Understanding how IFN levels differ between these groups may help clarify whether IFN patterns in cancer patients resemble those seen in autoimmune disease.\n\nParticipants in both groups will be asked to provide small blood samples at predefined time points during their clinical care or treatment. Researchers will measure the levels of different IFN types in all samples to compare IFN levels between cancer patients and individuals with autoimmune diseases, and within the cancer group between patients who develop irAEs and those who do not. The long-term aim of the study is to develop a simple test that can help clinicians identify patients at higher risk of irAEs.\n\nImmune-related adverse events (irAEs) are a frequent complication in cancer patients treated with immune checkpoint inhibitors (ICIs), and they often resemble or exacerbate preexisting autoimmune diseases. Despite extensive research in the field, no validated predictive biomarkers of irAEs currently exist. Emerging evidence suggests that the IFN signature -long implicated in the pathogenesis of several systemic autoimmune diseases (SADs)- may also be upregulated in patients who develop ICI-induced irAEs, likely with substantial overlap among different IFN subtypes. Given these clinical and molecular similarities with SADs, it is plausible that IFN levels in peripheral blood carry predictive value for irAE risk, although the dominant IFN types in ICI-related toxicity remain unknown.\n\nThe INTER-AUTENTIC project aims to determine whether baseline IFN levels and their dynamic changes, measured in peripheral blood using a dedicated panel, can predict the onset of irAEs in cancer patients receiving ICIs. Supported by the Medical Oncology departments of six university hospitals in Northern Spain, this multicenter, observational, prospective cohort study has been underway since 2021. Biobank samples have been collected from ICI-treated patients before treatment initiation, at protocol-defined time points, and at the moment of irAE diagnosis (ICI cohort). The study seeks to identify the IFN subtypes with the most pronounced differential expression between patients with and without irAEs, and to evaluate whether IFN levels enhance the predictive performance of a model incorporating other clinical variables potentially associated with immune-mediated toxicity. A sample size of 300 cancer patients has been estimated for this analysis.\n\nIn addition, a second prospective cohort of 40 non-cancer patients with systemic lupus erythematosus, primary Sjögren's syndrome, systemic sclerosis, and\u002For idiopathic inflammatory myopathy (SAD cohort) will be included. Since IFNs play a well-established pathogenic role in these conditions, this cohort will allow characterization of the IFN signature at key follow-up points (baseline, remission, and disease flare) and comparison with the IFN profiles of ICI-treated patients, regardless of whether they develop irAEs.",[515,29,516,517,518,519],"Immune-Related Adverse Events","Sjogren Syndrome","Systemic Sclerosis (SSc)","Inflammatory Myopathies","Solid Tumors",[521,522,523,524,525,526],"Immune Checkpoint Inhibitors","Adverse events","Biomarkers","Predictive","Prospective Studies","Immune System","2025-11-25",{"date":529,"type":40},"2025-12-03",{"date":531,"type":40},"2024-01-08",{"date":533,"type":22},"2026-12",{"name":535,"class":229},"Hospital Universitario Araba",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":548,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":71},"100583819","phase-1-vunakizumab-for-the-treatment-of-mild-to-moderate-systemic-lupus-erythematosus-100583819","NCT06881290","Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus","Pilot Study on the Treatment of Vunakizumab in Mild to Moderate Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Patients aged 18-65 years meeting the 2019 EULAR\u002FACR classification criteria for SLE.\n2. SLEDAI score was within 2-12 scores (with clinical SLEDAI \\[cSLEDAI\\] ≠ 0).\n3. Occurence of new or recurrent mucocutaneous or joint involvement.\n4. Stable standard treatment regimen prior to study entry but not effect: Prednisone or equivalent corticosteroid dose ≤ 20 mg per day for more than 4 weeks; Immunosuppressant less than 1 type for more than 12 weeks, including methotrexate ≤15 mg per week, azathioprine ≤100mg per day, mycophenolate mofetil ≤1.5 g per day, tacrolimus ≤2 mg per day, cyclosporine ≤150 mg per day). Antimalarials was permitted.\n5. Body mass index (BMI) 18-35 kg\u002Fm² at screening.\n6. Clinically eligible for Vunakizumab combination therapy with corticosteroids after investigator assessment.\n7. Willing to provide written informed consent with demonstrated compliance.\n\nExclusion Criteria:\n\n1. SLE with major organ dysfunction including Encephalopathy\u002Fcognitive impairment, Renal insufficiency, Cardiac insufficiency (NYHA class III-IV), Pulmonary hypertension\u002Finterstitial lung disease\n2. Active SLE-related organ involvement: Lupus cerebritis, Active lupus nephritis (proteinuria ≥1g\u002F24h), Myocardial involvement, Gastrointestinal vasculitis, Diffuse alveolar hemorrhage, Thrombocytopenic purpura, Hemophagocytic syndrome, Retinopathy\n3. Concurrent autoimmune diseases affecting efficacy assessment (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis).\n4. Liver dysfunction: ALT\u002FAST \\>1.5×ULN or total bilirubin \\>1×ULN.\n5. Active malignancy within 5 years or history of malignancy.\n6. Comorbidities requiring corticosteroids (e.g., asthma, Crohn's disease).\n7. Active infections requiring treatment:Tuberculosis, HBV\u002FHCV\u002FHIV\u002FCMV infections\n8. Major surgery within 3 months prior to screening.\n9. Hypersensitivity or intolerance to funakizumab.\n10. Pregnancy, lactation, or planned pregnancy.\n11. Biologic therapy within 3 months (anti-CD20 agents, belimumab, TNF-α inhibitors).\n12. Recent intensive therapies: Systemic corticosteroids within 3 months\u002F Plasmapheresis\u002FIVIG\u002Fcyclophosphamide within 3 months\n13. Any condition deemed by investigators to compromise study completion or patient safety.","65 Years",{"count":48,"type":22},[25],"Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by heterogeneous clinical manifestations ranging from mild cutaneous involvement to severe multi-organ damage. While its pathogenesis involves complex cytokine dysregulation, emerging evidence implicates IL-17 as a potential contributor. Elevated serum IL-17 levels have been observed in SLE patients compared to healthy controls, with heightened expression detected in renal and cutaneous lesions. Ustekinumab, a monoclonal antibody targeting IL-23\u002FIL-12 that indirectly modulates IL-17 signaling, demonstrated superior efficacy and safety to placebo in an SLE clinical trial, particularly in glucocorticoid dose reduction. Notably, no clinical trials have directly evaluated IL-17-targeted therapies for SLE, though case reports suggest secukinumab (an anti-IL-17A agent) may improve cutaneous manifestations in psoriasis-SLE overlap patients.\n\nVunakizumab, a humanized anti-IL-17A monoclonal antibody (IgG1\u002Fκ) with a unique epitope-binding profile, selectively inhibits IL-17A-mediated inflammatory signaling. Its established safety profile and infrequent dosing regimen in IL-17-mediated diseases (e.g., psoriasis, psoriatic arthritis) warrant investigation in SLE. The investigators aim to provide new treatment options for SLE patients",[29],[549,550],"Vunakizumab","Systemic lupus erythematosus","2025-07-07",{"date":553,"type":40},"2025-07-10",{"date":555,"type":40},"2025-05-19",{"date":557,"type":22},"2027-12-01",{"name":559,"class":229},"Chinese SLE Treatment And Research Group",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":543,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":71},"100568731","phase-1-anti-cd19-car-t-cell-therapy-in-refractory-systemic-autoimmune-diseases-100568731","NCT06685042","Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases","CATARSIS","Inclusion criteria\n\n* General\n\n  1. Subjects must understand and voluntarily sign an informed consent form, including written consent for data protection;\n  2. Adults aged ≥ 18 years and \\\u003C 65 years at time of consent;\n  3. Male subjects, unless surgically sterile, must agree to use two acceptable methods for contraception (e.g., spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP;\n  4. Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index \\\u003C1) starting from the time of signing the ICF and for 12 months after dosing of the IMP;\n  5. Must be able to adhere to the study visit schedule and other protocol requirements;\n  6. Double vaccination (2 doses) against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.\n* SLE subjects\n\n  a) Fulfilling the 2019 ACR\u002FEULAR classification criteria of SLE; b) Presence of anti-dsDNA, anti-histone, anti-nucleosome or anti-Sm antibodies; c) Active disease at screening, defined as ≥1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥2 organ systems with a BILAG B score (moderate disease activity); d) Insufficient response to glucocorticoids and at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab.\n* SSc subjects\n\n  1. Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc;\n  2. Diffuse SSc with respective autoantibody profile;\n  3. Signs for fast progression including i) disease duration ≤5 years (from onset of first non-Raynaud manifestation), ii) mRSS score 10-35 at screening, iii) elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, ESR ≥ 28mm\u002Fh or platelet count ≥ 330 000\u002Fmm3), iii) mRSS increase ≥ 3 units or involvement of one new body area or mRSS increase ≥ 2 units in one body area or ≥1 tendon friction rub over 6 months;\n  4. Insufficient response to glucocorticoids and to at least 2 of the following treatments:\n\nmycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab.\n\n* DM\u002FPM subjects\n\n  a) Fulfilling the 2017 ACR\u002FEULAR classification criteria for probable or definite DM or PM57, b) Muscle weakness as defined by MMT \\\u003C 142 and 2 of the following criteria: VAS patients Global ≥ 2 cm, VAS physician Global ≥ 2 cm, HAQ \\> 0.25, at least one muscle enzyme \\>1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2 cm; c) Presence of at least one myositis-specific antibody; d) Insufficient response to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, and intravenous immunoglobulins.\n* AAV subjects\n\n  1. Fulfilling the 2022 ACR\u002FEULAR classification criteria for MPA\u002FGPA\u002FEGPA,\n  2. Presence of ANCA to either proteinase 3 or myeloperoxidase;\n  3. At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS;\n  4. Failure of at least 1 of the following treatments: glucocorticoids, cyclophosphamide, or B-cell targeting therapy.\n\nExclusion criteria\n\n* Clinically suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the investigator;\n* ANC \\\u003C 1.000\u002Fmm3, ALC \\\u003C 500\u002Fmm3 or hemoglobin \\\u003C 8 g\u002Fdl, absolute CD3+ T cell count ≤100\u002Fµl;\n* Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.\n* Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia, congestive heart failure, or left ventricular ejection fraction \\\u003C 50%, as determined by echocardiography\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study;\n* Impaired renal function, i.e., eGFR \\\u003C 30 ml\u002Fmin;\n* Patients with evidence on thorax CT of advanced fibrotic interstitial lung disease and whose latest pulmonary function test showed a Forced Vital Capacity (FVC) \\\u003C 40% of predicted or a Diffusing Capacity for Carbon Monoxide (DLCO) \\\u003C 30% of predicted\n* Any concomitant severe active infection, including HIV (even with negative viral load), active hepatitis B (either positive for Hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\] and NAT tests) and\u002For C (\\\u003C12 weeks between achievement of a sustained virological response to the specific treatment and apheresis) according to the American Association for the Study of Liver Diseases guidelines, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If the presence of latent tuberculosis is established, then treatment according to local guidelines must have been initiated before enrolment;\n* Pregnant or lactating females;\n* Known hypersensitivity to either any drug components or any auxiliary medicinal products scheduled during trial participation, including during lymphodepletion;\n* Malignancy in the last 5 years before screening. The inclusion of patients with previously completely resected carcinoma in situ who have not required treatment other than surgery is allowed.\n* Previous CAR T cell administration;\n* A therapeutic schedule not compatible with the wash-out requirements for the leukapheresis procedure (section 5.8.1 of CSP) and the medications permitted during the study (section 7.11 of CSP);\n* Concurrent treatment with other investigational agents or participation in other investigational trials.\n* Treatment, as part of an investigational clinical trial, with an experimental product with a definite or potential effect on T or B-cells in the previous 2 years.\n* Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis;\n* Subjects who are younger than 18 years or are incapable of understanding the aim, importance, and consequences of the study and giving legal informed consent;\n* Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration or may interfere with the interpretation of results;\n* Subjects who possibly are dependent on the Sponsor, the Principal Investigator, or the Investigator (e.g., family members).\n* Limited to patients diagnosed with SLE: patients with a history of severe central nervous system (CNS) involvement, including those who have presented aseptic meningitis, cerebral vasculitis, cerebrovascular disease, demyelinating syndrome, myelopathy, seizure disorder, status epilepticus, and severe lupus headache, will be excluded.\n* Patients meeting the classification criteria for multiple connective diseases such as overlapping SLE and Sjogren's Syndrome (SS) or SLE and Rheumatoid Arthritis (RA) and patients diagnosed with Mixed Connective Tissue Disease (MCTD).",{"count":568,"type":22},8,[25,26],"The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM\u002FPM, and AAV. These life-threatening conditions often resist current therapies, and B cells play a key role in their pathogenesis. The study employs CD19-CAR\\_Lenti, an autologous CAR T-cell product targeting CD19-positive B cells, aiming to reduce inflammation and autoimmunity. This open-label, single-dose, phase I basket trial will assess the safety, feasibility, and preliminary efficacy of CAR T-cell therapy, focusing on adverse events, infection rates, and overall response at 24 weeks. Eight participants will be included.",[29,572,573,361,574],"System; Sclerosis","ANCA Associated Vasculitis","Polymyositis",{"date":576,"type":40},"2025-04-11",{"date":578,"type":40},"2024-11-29",{"date":580,"type":22},"2025-12",{"name":582,"class":229},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":590,"conditions":591,"keywords":592,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":71},"100584298","chinese-rheumatism-biobankcrb-100584298","NCT06887517","Chinese Rheumatism Biobank(CRB)","Inclusion Criteria:\n\n1. Patients meet the 2012 SLICC classification criteria or 2019 ACR\u002FEULAR classification criteria of SLE.\n2. Disease Duration ≤2 years since SLE diagnosis at baseline\n3. Non-Organ-Threatening Disease, including BILAG-2004 categories A\u002FB\u002FC in neurological, cardiopulmonary, gastrointestinal, ophthalmic, renal, or hematological domains\n\n   Specifically excluded:\n\n   Renal: Cellular casts, hematuria (\\>5 RBC\u002Fhpf), proteinuria (\\>0.5g\u002F24hr), pyuria (\\>5 WBC\u002Fhpf), or biopsy-proven lupus nephritis Neuropsychiatric: Seizures, psychosis, organic brain syndrome, cerebrovascular events Cardiopulmonary: Pulmonary arterial hypertension, myocarditis, pulmonary hemorrhage Vasculitis: Ulcerative\u002Fnecrotizing lesions or biopsy-proven vasculitis Hematologic: Hemolytic anemia, thrombocytopenia (\\\u003C100×10⁹\u002FL) No acute thromboembolic events within 3 months\n4. Treatment History:\n\n   No systemic corticosteroids, plasmapheresis, or IVIG within 3 months No biologics (e.g. belimumab, TNF-α inhibitors) within 3 months No cyclophosphamide or CD20 inhibitors within 6 months\n5. Disease Activity: Clinical SLEDAI-2K \\>0 at screening\u002Fbaseline\n\nExclusion Criteria:\n\n1. SLE with coexisting other autoimmune or autoinflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.\n2. SLE with concurrent conditions requiring glucocorticoid therapy, such as asthma or Crohn's disease.\n3. Pregnancy, planned pregnancy, or lactation.\n4. SLE with major organ dysfunction at baseline , including: impaired consciousness or cognitive decline, renal insufficiency, cardiac insufficiency (NYHA Class 3 or 4), pulmonary hypertension or interstitial lung disease, uncontrolled infections\n5. Inability to ensure compliance with long-term follow-up\n6. Any condition deemed by investigators to compromise trial completion or pose significant risks",{"count":166,"type":22},"Early prediction of major organ damage in SLE needs to dynamically track the evolution of SLE patients before and after the onset of major organ damage, and analyze the microscopic molecular evolution patterns synchronized with the macroscopic pathophysiological changes.",[29],[593,594,595],"systemic lupus erythematosus","major organ damage","progress of disease","2025-04-07",{"date":598,"type":40},"2025-04-09",{"date":600,"type":40},"2025-02-10",{"date":602,"type":22},"2033-04-01",{"name":559,"class":229},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":543,"enrollmentInfo":611,"targetDuration":613,"studyType":189,"phases":4,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":71},"100586736","physical-activity-in-patients-with-systemic-lupus-erythematosus-100586736","NCT06919250","Physical Activity in Patients With Systemic Lupus Erythematosus","Physical Activity and Its Impact on Health in Patients With Systemic Lupus Erythematosus. A Multicenter Cohort Study.","Inclusion Criteria:\n\n* Patients with a diagnosis of systemic lupus erythematosus\n* Of legal age\n* Residents in Spain\n* Who sign the informed consent document.\n\nExclusion Criteria:\n\n* Patients dependent in the development of activities of daily living.\n* Unable to ambulate without the help of third parties.\n* Who have undergone surgery in the last 6 months.",{"count":612,"type":22},63,"1 Day","Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients.\n\nObjective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it.\n\nMethod. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients.\n\nExpectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.",[29],[33,617,618,619],"Physical activity","Prevention","Physiotherapy","2025-04-04",{"date":598,"type":40},{"date":623,"type":22},"2025-03-31",{"date":625,"type":22},"2025-05-20",{"name":627,"class":229},"University of Oviedo",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":71},"100540434","early-phase-1-exploratory-clinical-study-of-cnct19-anti-cd19-cell-therapy-in-the-treatment-of-refractory-autoimmune-diseases-100540434","NCT06316791","Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n1. The enrolled subjects or their legal representatives signed informed consent form;\n2. age range: 18-70 years (including 18 and 70 years), male or female;\n3. Subjects with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia) : Diagnosed with systemic lupus erythematosus according to American College of Rheumatology (ACR) criteria, accompanied by lupus nephritis (SLE-LN) or immune thrombocytopenia (SLE-ITP) and receiving standard treatment;\n\n   1. Subjects with Refractory Systemic Lupus Erythematosus (Lupus Nephritis): Active and biopsy-confirmed proliferative lupus nephritis grade III or IV or simple grade V alone according to 2003 ISN\u002FRPS criteria. Active renal disease was defined as a urine protein: creatinine ratio \\> 1.0 or proteinuria \\> 3.5 grams\u002Fday.\n   2. Subjects with refractory systemic lupus erythematosus (thrombocytopenia): At least two consecutive blood routine examinations showed that platelet was lower than 50x109\u002FL; Blood cell morphology of peripheral blood smear was normal. The spleen is generally not enlarged; The morphological characteristics of bone marrow cells were megakaryocytic increase or normal, accompanied by maturation disorder. Platelet count \\> 10 x10\\^9 \u002F L.\n4. Subjects with refractory ANCA-associated vasculitis: diagnosis of ANCA glomerulonephritis (GN) or vasculitis based on the 2013 American Chapel Hill Consensus Conference definition of AAV ;\n\n   * Relapsed or refractory AAV requiring treatment with cyclophosphamide or rituximab\n   * Newly diagnosed or recurrent AAV--, defined as accumulation of at least one major organ (e.g., kidney, lung, heart) requiring induction therapy with cyclophosphamide or rituximab;\n   * Anti-PR3 or anti-MPO positive (current or history);\n5. Subjects with Refractory Dermatomyositis: Refractory MDA5-positive dermatomyositis is defined as active disease and meets the following conditions: adequate corticosteroid therapy (greater than two to four weeks of conventional corticosteroid therapy or intolerance to such therapy) and\u002For\n\n   * Use of ≥ 1 conventional immunosuppressive agent (eg, methotrexate, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil, IVIG, anti-TNF, or rituximab) at a reasonable dose and duration (greater than two to four weeks or intolerance to therapy);\n   * Treatment with IVIG or cyclophosphamide for two to four weeks.\n6. Women of childbearing potential must have a negative blood pregnancy test 7 days prior to trial conditioning therapy; any male and female patients of childbearing potential must agree to use an effective method of contraception throughout the study and for at least 1 year following reinfusion of CNCT19 CAR-T cells. Childbearing potential, in the judgment of the investigator, is biologically capable of bearing a living baby and sexually active. Female patients who were not of childbearing potential (ie, met at least 1 of the following criteria):\n\n   * Hysterectomy or oophorectomy, or\n   * Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence of pathological or physiological causes).\n7. Adequate organ function according to the following criteria:\n\n   * Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) ≤ 3 times ULN;\n   * Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert's syndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included;\n   * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft and Gault formula), Patients with lupus nephritis may relax the conditions appropriately according to the judgment of the investigator;\n   * Must have minimal pulmonary reserve and oxygen saturation \\> 91% in a nonoxygenated state;\n   * Lymphocyte count \\> 0.4 × 109\u002FL.\n\nExclusion Criteria:\n\n1. Patients with severe active central nervous system (CNS) lupus, including seizures, psychosis, cerebrovascular accident or CNS vasculitis requiring therapeutic intervention within 60 days after baseline;\n2. Dialysis patients;\n3. Pregnancy or lactation;\n4. Concomitant uncontrollable infection (e.g., sepsis, bacteremia, fungemia, uncontrolled pulmonary infection, etc.);\n5. Hepatitis B surface antigen (HBsAg) positive and hepatitis C (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis (TP) positive;\n6. Major surgery that was assessed as unsuitable by the investigator within 4 weeks before screening;\n7. Patient's heart meets any of the following:\n\n   * Left ventricular ejection fraction (LVEF) ≤ 45%;\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure or active cardiac disease;\n   * Serious arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia);\n   * QTc interval ≥ 450 ms for males and ≥ 470 ms for females (QTcB = QT\u002FRR1\u002F2);\n   * Myocardial infarction, bypass surgery or stent surgery within 6 months prior to the study;\n   * Other cardiac diseases that are not suitable for the study as judged by the investigator;\n8. Received live vaccine within 6 weeks prior to screening.\n9. Participation in other interventional clinical studies within 3 months prior to cell infusion, treatment with an active experimental drug, or intentional participation in another clinical trial or treatment outside of that specified by the protocol throughout the study period.\n10. Patients with a history of epilepsy or other active central nervous system diseases;\n11. Known hypersensitivity to the ingredients of the preparation used in the test;\n12. Prior treatment with CAR-T cells.\n13. Other conditions that the investigator considers inappropriate for participation in this clinical trial.",{"count":635,"type":22},24,[637],"EARLY_PHASE1","Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.",[29],[641,642],"CNCT19","CD19-directed CAR-T cells","2025-02-06",{"date":600,"type":40},{"date":646,"type":40},"2021-12-14",{"date":648,"type":22},"2025-12-13",{"name":650,"class":47},"Juventas Cell Therapy Ltd.",{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":659,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":291},"100454134","anti-c1s-anti-hmgb1-and-anti-c1q-autoantibodies-in-systemic-lupus-erythematosus-dysalarm-322-100454134","NCT05193591","Anti-C1s, Anti-HMGB1 and Anti-C1q Autoantibodies in Systemic Lupus Erythematosus (DYSALARM-322)","Evaluation of Anti-C1s, Anti-HMGB1 and Anti-C1q Autoantibodies in the Pathogenesis for Patients With Systemic Lupus Erythematosus (SLE)","DYSALARM-322","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Weight ≥ 40 Kg\n* Patients who have valid health insurance\n* Patients with lupus diagnosis criteria (EULAR-ACR-2019)\n* Active lupus nephritis defined by SLEDAI score \\>5 and joint and\u002For kidney involvement.\n\nExclusion Criteria:\n\n* Patient protected by law (minors, pregnant or breastfeeding women, subject under guardianship or curatorship, deprived of liberty or enforced hospitalized, under administrative or judicial supervision).\n* Patient on dialysis or on plasma exchange.",{"count":300,"type":22},"Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies and accumulation of immune complexes resulting in systemic inflammatory response and tissue damage.\n\nDysfunction of proteins initially known to initiate the classical pathway for complement activation (C1q and C1s), and their functional interference with the multifunctional protein HMGB1 (High-Mobility Group Box 1), appears to be associated with SLE. On the other hand, C1s, HMGB1 and C1q can be targeted by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies from lupus patients, whose functional impact remains to be explored, in particular for non-canonical functions, independent of the complement activation cascade.\n\nStudies are needed to investigate the pathogenic role of these autoantibodies in SLE, including possible interference with the inactivation of HMGB1.\n\nThis project plans to investigate the role of anti-C1s, anti-HMGB1 and anti-C1q autoantibodies in the pathogenesis of Systemic Lupus Erythematosus. This pilot study will be performed for 30 patients with active SLE on serum, realized for routine patient care. The investigators will identify the molecular targets recognized by anti-C1s, anti-HMGB1 and anti-C1q autoantibodies purified from the SLE patients' serum. The investigators will also explore the functional role of these purified autoantibodies.",[29],"2024-08-29",{"date":664,"type":40},"2024-08-30",{"date":666,"type":40},"2022-03-11",{"date":668,"type":22},"2025-09-10",{"name":670,"class":229},"University Hospital, Grenoble",{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":4,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":678,"targetDuration":4,"studyType":23,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":685,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":71},"100559664","phase-1-jwcar201-for-the-treatment-of-hematology-malignancy-and-autoimmune-diseases-100559664","NCT06567080","JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases","An Open Label, Single Arm Study to Evaluate JWCAR201 Treating B Cell Driven Hematology Malignancy and Autoimmune Diseases","Inclusion Criteria:\n\nFor subjects with B cell driven malignancy (relapsed\u002Frefractory large B cell lymphoma)\n\n1. aged \\>= 18 years\n2. willing to sign ICF\n3. with histologically confirmed large B cell lymphoma and immunohistochemically positive CD20\n4. The subject must have previously been treated with an anthracycline and rituximab (or another CD20-targeted therapy), and must have relapsed, not achieved remission, or experienced disease progression after receiving at least two lines of therapy, including autologous hematopoietic stem cell transplantation (autoHSCT)\n5. The subject must have CT measurable lesions and PET evaluable lesions as determined by the Lugano criteria.\n6. The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nFor subjects with SLE:\n\n1. Voluntarily sign the informed consent form (ICF).\n2. At the time of signing the ICF, be between 18 and 70 years old (inclusive of 18 and 70 years), with no restriction on gender.\n3. Have been diagnosed with SLE (Systemic Lupus Erythematosus) for ≥ 6 months before screening, according to the 2019 EULAR\u002FACR revised criteria\n4. Have previously required treatment with corticosteroids combined with immunosuppressants and biologics, with the treatment regimen stable for \\>2 months and the dose stable for \\>2 weeks before screening, yet the disease remains active.\n5. At the time of screening, positive for antinuclear antibodies (ANA), and\u002For anti-dsDNA antibodies, and\u002For anti-Smith antibodies.\n6. SLEDAI-2K score ≥ 7 points during the screening period.\n\n   Exclusion Criteria:\n\n   For subjects with B cell driven malignancy (relapsed\u002Frefractory large B cell lymphoma)\n\n1\\. Primary central nervous system (CNS) lymphoma (subjects with secondary CNS lymphoma are allowed to enroll).\n\n2\\. A history of another malignancy that has not been in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with a low likelihood of recurrence, treated localized prostate cancer, biopsy-confirmed in situ cervical cancer, or squamous intraepithelial lesions identified on a PAP smear).\n\n3\\. At the time of screening, the subject has:\n\n1. Hepatitis B surface antigen (HBsAg) positivity (regardless of whether or not there is an increase in hepatitis B virus DNA copies).\n2. Hepatitis B core antibody (HBcAb) positivity with an increase in hepatitis B virus DNA copies.\n3. Hepatitis C, HIV, or syphilis infection. 4. The subject has had active deep vein thrombosis (DVT) (tumor thrombus or blood clot) or pulmonary embolism (PE) within 3 months prior to signing the informed consent form.\n\n5\\. The subject has been undergoing anticoagulant therapy for active DVT or PE within 3 months prior to signing the informed consent form (prophylactic treatment is excluded).\n\n6\\. Uncontrolled systemic fungal, bacterial, viral, or other infections. 7. Acute or chronic graft-versus-host disease (GvHD). 8. History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.\n\n9\\. Clinically significant CNS diseases within the past 6 months or at the time of screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders.\n\n10\\. Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the start of lymphodepleting chemotherapy.\n\n11\\. The investigator determines that the subject has any factors that could affect compliance with the protocol, including uncontrolled medical, psychological, familial, sociological, or geographical conditions; or the subject is unwilling or unable to comply with the procedures required by the study protocol.\n\n12\\. The subject has previously received CAR-T cell therapy or other gene-modified T cell therapy.\n\nFor subjects with SLE:\n\n1. Severe lupus nephritis requiring hemodialysis within 2 months before screening, or treatment with prednisone ≥ 100 mg\u002Fday or equivalent corticosteroids for ≥ 14 days.\n2. Lupus crisis within 1 month before screening, deemed unsuitable for participation in this study by the investigator.\n3. Clinically significant central nervous system disease or pathological changes not caused by lupus before screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures\u002Fconvulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, intellectual disability, visual impairment, etc.\n4. Concurrent other autoimmune diseases requiring systemic treatment.\n5. History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n6. At the time of screening:\n\n1)Active hepatitis B. 2)Hepatitis C, HIV, or syphilis infection. 7. History of any of the following cardiovascular diseases within 6 months before screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases.\n\n8\\. Use of any other investigational drug for SLE within 1 month before screening. However, if the investigational treatment was ineffective or the disease relapsed during the study treatment period, and at least 3 half-lives of the drug have passed before screening, the patient may be eligible for enrollment.\n\n9\\. Previous treatment with CAR-T cells or other gene-modified T cell therapies. 10. History of ≥ Grade 2 bleeding within 30 days before screening, or the need for long-term continuous use of anticoagulant medications (such as warfarin, low molecular weight heparin, or factor Xa inhibitors).\n\n11\\. Undergoing plasmapheresis, plasma exchange, or hemodialysis within 14 days before screening.\n\n12\\. Use of any live vaccines for infectious diseases within 1 month before screening.\n\n13\\. Known life-threatening allergic reaction, hypersensitivity, or intolerance to JWCAR201 cell product or its excipients (including dimethyl sulfoxide (DMSO)).",{"count":679,"type":22},15,[25],"JWCAR201 is a CD19\u002FCD20 CAR-T product. This trial is intended to evaluate the safety, PK\u002FPD and efficacy of JWCAR201 in patients with B cell driven hematology malignancy and autoimmune diseases",[683,278,29,684],"B-cell Tumors","Large B-cell Lymphoma","2024-08-19",{"date":687,"type":40},"2024-08-22",{"date":689,"type":22},"2024-09",{"date":691,"type":22},"2027-03",{"name":693,"class":229},"RenJi Hospital"]