[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-lupus-erthematosus-sle\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-lupus-erthematosus-sle":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,76,107,138,168,191,220,242,265,285,308],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100649075","phase-1-baff-car-t-cells-lmy-922-for-treatment-of-refractory-autoimmune-disease-100649075",false,"NCT07729995","BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease","A Phase 1 Study of Allogeneic (γ\u002Fδ) BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease","Inclusion Criteria:\n\nParticipants must meet all the following inclusion criteria to be eligible for enrollment:\n\n1. Male or female 16-75 years of age, inclusive.\n2. For participants with:\n\n   a. Rheumatoid Arthritis:\n\n   i. Meets criteria for seropositive, adult-onset RA as defined by the 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria, or seropositive (rheumatoid factor positive) polyarticular juvenile arthritis as defined by the International League of Associations for Rheumatology (ILAR) classification criteria for at least 3 months prior to screening\n\n   ii. Disease Activity Score DAS28-ESR\\>3.2 at screening.\n\n   iii. At least one swollen joint with Power Doppler activity of at least grade 1 or B-mode activity of at least grade 2 at screening.\n\n   iv. Inadequate response to at least one csDMARD and at least two tsDMARD\u002FbDMARDs with two different mechanisms of action.\n\n   v. Rheumatoid factor or ACPA positivity (cut off 20 mU\u002Fml) at screening.\n\n   b. Systemic Lupus Erythematosus:\n\n   i. Meets European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria for Systemic Lupus Erythematosus prior to screening\n\n   ii. Participant must be positive for at least one of the following at screening: Anti-dsDNA (above the upper limit of normal \\[ULN\\]); or anti-Sm (above the ULN); or anti-chromatin\n\n   iii. An inadequate response to at least two immunomodulatory agents (cyclophosphamide, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil) and one biologic agent (e.g., belimumab, anifrolumab)\n\n   iv. Diagnosed with active SLE based on at least one of the following: 1. Active non-renal SLE with SLEDAI score ≥6 at screening; 2. Biopsy proven lupus nephritis (LN) with a urine protein creatinine ratio of ≥1 mg\u002Fmg on a first morning void. A biopsy must be performed in the 6 months prior to the screening showing active LN class III or IV, with or without class V, in accordance with the 2018 International Society of Nephrology\u002FRenal Pathology Society classification.\n\n   c. Dermatomyositis:\n\n   i. Meets 2017 EULAR\u002FACR Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies for definite or probable diagnosis of DM or juvenile DM at least 6 months before screening.\n\n   ii. Positivity for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma)\n\n   iii. Active DM as defined by at least one of the following: Active skin disease as defined by a CDASI-A score of at least 14, or active muscle disease as defined as Manual Muscle Testing (MMT-8) score \\\u003C142\u002F150 and creatine kinase, aldolase, LDH, AST, or ALT ≥2×ULN (if deemed due to muscle inflammation by investigator) and MRI evidence of active myositis within last 3 months.\n\n   iv. Failure of at least 2 standard-of-care therapies, including csDMARDs + corticosteroids and bDMARD or IVIG\n\n   v. Inadequate response to intravenous immunoglobulin (IVIG) and at least two immunomodulator agents: cyclophosphamide, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil and one biologic agent (e.g., rituximab, belimumab).\n\n   d. Systemic Sclerosis:\n\n   i. Per 2013 ACR\u002FEULAR classification criteria and all of the following: 1. Disease duration of ≤ 3 years (time from the first non-Raynaud phenomenon manifestation); 2. mRSS \\> 10 at screening with early disease or rapid progression, or mRSS ≥ 15 with disease duration ≥ 18 month.; 3. Positivity for at least one SSc-specific parameter (Scl70, RNA polymerase, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies); 4. Failure of treatment with at least 2 standard-of-care therapies, including ≥2 csDMARDs (including mycophenolate or cyclophosphamide) and ≥1 bDMARD (including rituximab); 5. Diffuse SSc with or without interstitial lung disease (ILD)\n3. Stable doses of corticosteroids for at least 4 weeks and other immunosuppressives for 8 weeks.\n4. Adequate organ function as defined by each of the following:\n\n   1. Creatinine clearance more than or equal to 45 ml\u002Fmin calculated per the 2021 CKD-EPI Creatinine Equation\n   2. Participants must have adequate cardiac function as defined as left ventricular ejection fraction ≥ 45% on the most recent echocardiogram and no clinically significant arrhythmias, pericardial effusion, valvular, or ischemic heart disease.\n   3. Adequate pulmonary function with pulse oximetry ≥92% on room air.\n   4. Total Bilirubin \\\u003C 1.5× the institutional upper limit of normal (except in participants with Gilbert's syndrome).\n   5. ALT (SGPT) and AST (SGOT) \\\u003C 1.5× the institutional upper limit of normal (except for participants with active myositis).\n   6. Hemoglobin ≥ 8.5 g\u002FdL, and no red blood cell transfusion within 60 days before the laboratory test.\n   7. Platelets ≥ 100,000\u002FμL, no transfusion support within 7 days before the laboratory test, and no associated bleeding.\n   8. Absolute neutrophil count ≥1000.\n5. Participants (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n6. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after the BAFF CAR-T cell infusion.\n\n   A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\n   Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 1 year after the BAFF CART cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 1 year after the BAFF CAR-T cell infusion to avoid potential embryonal or fetal exposure.\n\n   The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n8. Body weight of at least 55kg for participants treated at Dose Level 3 (450 × 10\\^6 BAFF+ CAR cells) and at least 37kg for all other dose levels.\n9. Participants must be vaccinated per institutional guidelines at least four weeks prior to lymphodepletion.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a participant from study enrollment:\n\n1. Significant disease-related complications\n\n   a. For Systemic Lupus Erythematosus participants:\n\n   i. Features of severe neuropsychiatric lupus, including seizures, psychosis, stroke, lupus cerebritis or lupus meningitis. Prior history of severe neuropsychiatric lupus with active features should be discussed with the medical monitor\n\n   ii. Active secondary hemophagocytic lymphohistiocytosis (sHLH)\u002Fmacrophage activation syndrome (MAS)\n\n   iii. History of antiphospholipid syndrome diagnosed by ACR\u002FEULAR criteria (isolated obstetric antiphospholipid syndrome is allowed) b. For Dermatomyositis participants: i. Overlap myositis\u002Fconnective tissue disease (except for overlap with Sjögren's syndrome) ii. Participants with other types of myositis or myopathies: polymyositis, paraneoplastic myositis, inclusion body myositis, metabolic or drug induced myopathy, dystrophies\n\n   c. For Systemic Sclerosis participants:\n\n   i. Anticentromere antibody seropositivity\n\n   ii. SSc mimics (eg, scleromyxedema, eosinophilic fasciitis)\n\n   iii. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers\n2. Active thrombotic thrombocytopenic purpura (TTP)\u002Fmicrothrombotic vasculopathy (TMA)\n3. Current or prior malignancy, unless the malignancy was treated with curative intent and the participant has no known active malignant disease present for ≥ 5 years prior to enrollment.\n4. Symptomatic congestive heart failure.\n5. Renal failure requiring regular dialysis.\n6. Uncontrolled pulmonary disease.\n7. Ongoing infection, whether controlled or uncontrolled.\n8. Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n9. Active infection requiring intravenous systemic treatment.\n10. HIV seropositivity.\n11. Pregnant or breastfeeding women are excluded from this study (breastfeeding should be discontinued), because there is an unknown, but potential risk for adverse events in fetuses and nursing infants secondary to treatment of the mother with LMY-922 and lymphodepleting chemotherapy. Women of childbearing potential must have a negative serum pregnancy test\n12. Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded.)\n13. Participants with history of clinically relevant CNS pathology such as uncontrolled epilepsy, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease.\n14. Participants with uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n15. Participants receiving a live vaccine within 2 weeks prior to screening.\n16. Concurrent use of high dose systemic steroids and\u002For immunosuppressive therapies.\n\n    1. Steroid dose must be able to be weaned to 0.5 mg\u002Fkg\u002Fday or equivalent prior to CAR-T cell infusion.\n    2. Immunosuppressive medications must be able to be stopped at least 5 halflives prior to CAR-T cell infusion.\n17. Treatment with rituximab or other B cell depleting agent within 6 months of planned CAR-T cell infusion, or treatment with agents such as etanercept, adalimumab, anakinra, infliximab, certolizumab pegol, belimumab, golimumab, abatacept, or tocilizumab within 4 weeks or 5 half-lives (whichever is shorter) prior to planned CAR-T cell infusion.\n18. Participants with IgG levels \\\u003C 600mg\u002FdL.","ALL","16 Years","75 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory autoimmune disease, even after relapse following other treatments. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against refractory autoimmune disease using a BAFF CAR-T cell manufacturing process with or without lymphodepletion regimen.",[27,28,29,30],"Rheumatoid Arthritis (RA)","Systemic Lupus Erthematosus (SLE)","Dermatomyositis (DM)","Systemic Sclerosis (SSc)",[32,33,34],"Systemic Scleroderma","Lupus","Lupus Nephritis","NOT_YET_RECRUITING","2026-07-21",{"date":38,"type":39},"2026-07-28","ACTUAL",{"date":41,"type":21},"2026-10",{"date":43,"type":21},"2030-03",{"name":45,"class":46},"Luminary Therapeutics","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100648364","non-invasive-assessment-of-subclinical-atherosclerosis-and-cardiovascular-risk-using-tyg-index-in-lupus-nephritis-100648364","NCT07719322","Non Invasive Assessment of Subclinical Atherosclerosis and Cardiovascular Risk Using TYG Index in Lupus Nephritis","Non Invasive Assessment of Subclinical Atherosclerosis in Relation to Triglyceride-Glucose (TyG) Index and Cardiovascular Risk in Lupus Nephritis a Single Center study_Assuit University","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diagnosis of SLE according to the 2019 ACR\u002FEULAR classification criteria for systemic lupus erythematosus.\n\n  * Lupus nephritis , classified according to the 2018 ISN\u002FRPS classification of lupus nephritis.\n\nExclusion Criteria:\n\n* Established cardiovascular disease (MI, stroke, PAD)\n* Diabetes mellitus\n* Hypertension\n* Patient with CKD\n* infections\n* other autoimmune diseases\n* Pregnancy\n* Malignancy\n* chronic liver disease\n* Dyslipidemia\n* Obesity\n* Patients on lipid lowering therapy","19 Years",{"count":57,"type":21},156,"OBSERVATIONAL","Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease characterized by loss of immune tolerance, autoantibody production, immune complex deposition, and complement activation, resulting in widespread inflammation and organ damage. Renal involvement, known as lupus nephritis (LN), occurs in approximately 40-60% of SLE patients and represents one of the most severe disease manifestations, significantly contributing to morbidity and mortality.Lupus nephritis arises from immune complex deposition in glomerular and tubulointerstitial structures, causing inflammatory and proliferative lesions that can progress to chronic kidney disease or end-stage renal disease. The ISN\u002FRPS classification provides a standardized histopathological framework essential for prognosis and guiding treatment decisions.\n\nIn addition to renal complications, patients with SLE and LN are at substantially increased risk of premature cardiovascular disease, which cannot be fully explained by traditional cardiovascular risk factors.Persistent systemic inflammation, endothelial dysfunction, dyslipidemia, and insulin resistance accelerate atherosclerosis in these patients. Subclinical vascular changes, including increased carotid intima-media thickness (CIMT) and carotid plaque formation, often precede overt cardiovascular events, underscoring the importance of early cardiovascular risk assessment The triglyceride-glucose (TyG) index is a validated surrogate marker of insulin resistance, correlating with endothelial dysfunction, subclinical atherosclerosis, and increased CIMT Elevated TyG index may therefore serve as a simple, non-invasive tool for early cardiovascular risk stratification in patients with lupus nephritis",[28,61],"Lupus Nephritis (LN)",[63,64,65],"triglyceride-glucose index","subclinical atherosclerosis","cardiovascular risk","2026-07-18",{"date":68,"type":39},"2026-07-22",{"date":70,"type":21},"2026-07",{"date":72,"type":21},"2029-07",{"name":74,"class":75},"Assiut University","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":47},"100647828","effect-of-anti-inflammatory-diet-in-systemic-lupus-erythematous-100647828","NCT07713940","Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous","Inclusion Criteria:\n\n* patients who meet the 2019 EULAR\u002FACR Classification Criteria for SLE\n* patients who are on Cellcept or Myfortic for at least 3 months prior to screening\n* patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.\n\nExclusion Criteria:\n\n* pregnant or lactating patients,\n* patients with food allergy\n* patients on antibiotics within 4 weeks of the screening\n* patients that change the SLE therapy during the length of the study (12 weeks).","18 Years",{"count":84,"type":21},36,[86],"NA","To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus",[28],[90,91,92,93,94,95,96],"lupus","diet","anti-inflammatory diet","mediterranean diet","cellcept","mycophenalate","microbiome","RECRUITING","2026-07-14",{"date":100,"type":39},"2026-07-20",{"date":102,"type":21},"2026-07-01",{"date":104,"type":21},"2029-07-01",{"name":106,"class":75},"University of California, San Diego",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":114,"minAge":82,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":47},"100610281","phase-2-2-hoba-in-systemic-lupus-erythematosus-100610281","NCT07225543","2-HOBA in Systemic Lupus Erythematosus","Scavenging IsoLGs in Autoimmune Disease: a Proof-of-concept Clinical Study","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥18 years\n* Female (biological)\n* Meeting the 2019 European League Against Rheumatism\u002F American College of Rheumatology classification criteria for SLE32\n* No change in immunosuppressants ≥3 months\n* Stable prednisone (or equivalent) dose ≤ 20mg\u002F day for ≥ 1 month\n* Elevated blood pressure defined as \\>120 and \\\u003C or = 160 mmHg systolic or \\>80 and \\\u003C or = 110 mmHg diastolic blood pressure at screening visit\n* No change in anti-hypertensive dose ≥2 weeks\n* Willingness to stop NSAIDs for ≥2 weeks before and throughout the study\n* If of childbearing potential, willingness to use effective birth control throughout the study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Male (biological)\n* Active cancer except for non-melanoma skin cancer\n* Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg\u002Fdl\n* Active infection requiring medical intervention\n* Major surgery in ≤ 3 months\n* Aspirin allergy\n* Use of MAO-I\n* Estimated creatinine clearance \\\u003C30 ml\u002Fmin\n* Known atrial fibrillation\n* Severe comorbid condition","FEMALE",{"count":116,"type":21},42,[118],"PHASE2","This is a phase II randomized, placebo-controlled, double-blind, cross-over study to determine the effect of isolevuglandin (IsoLG) scavenging by 2-HOBA on blood pressure and immune activation in patients with SLE. 42 patients with stable SLE will be randomized to treatment sequence to receive placebo or 500mg 2-HOBA three times a day for 8 weeks followed by a 4 week washout and then 8 weeks of the other agent.\n\nPrimary outcome measures include change in 24-hour blood pressure and NETosis. This study will provide mechanistic information on the role of IsoLGs in autoimmune disease-associated hypertension and immune activation.",[28],[122,123,90,124,125,126,127,128],"systemic lupus erythematosus","SLE","oxidative stress","hypertension","blood pressure","NETosis","isolevuglandins","2026-05-18",{"date":131,"type":39},"2026-05-22",{"date":133,"type":39},"2026-05-15",{"date":135,"type":21},"2030-07-31",{"name":137,"class":75},"Vanderbilt University Medical Center",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":47},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684","NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","3 Years",{"count":147,"type":21},15,[149],"EARLY_PHASE1","This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[152,28,153,154,30,155],"Autoimmune Diseases","Multi-Drug Resistant Nephrotic Syndrome","IgA Nephropathy (IgAN)","ANCA Associated Systemic Vasculitis",[157,153,28,154,30,158],"UCART","ANCA associated systemic vasculitis","2026-05-12",{"date":161,"type":39},"2026-05-14",{"date":163,"type":21},"2026-05-08",{"date":165,"type":21},"2030-12-31",{"name":167,"class":75},"The Children's Hospital of Zhejiang University School of Medicine",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":18,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":47},"100637500","a-study-to-evaluate-mtm-h-001-injection-in-adult-patients-with-b-cell-related-autoimmune-diseases-100637500","NCT07593911","A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases","An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)","ArchAid-002","Inclusion Criteria:\n\n* Key inclusion criteria include：\n\n  1. Male or female, aged 18 - 75 years old (inclusive);\n  2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n  3. Confirmed diagnosis of the target autoimmune disease per international classification criteria;\n  4. Adequate organ function to tolerate treatment;\n  5. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n* Key exclusion criteria include:\n\n  1. Active, severe, uncontrolled infection;\n  2. Pregnancy or breastfeeding women;\n  3. History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;\n  4. Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.",{"count":177,"type":21},75,[86],"This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.",[28,61,181,182,183,27],"Multiple Sclerosis","Myasthenia Gravis (MG)","IgG4-Related Diseases",{"date":129,"type":39},{"date":186,"type":21},"2026-06",{"date":188,"type":21},"2031-06",{"name":190,"class":75},"Beijing GoBroad Hospital",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":200,"conditions":201,"keywords":207,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":47},"100614362","the-rheumsafer-study-improving-medication-appropriateness-in-people-with-rheumatic-conditions-100614362","NCT07278609","The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions","Inclusion Criteria:\n\n* Aged ≥60\n* Followed by a rheumatologist at MUHC for an inflammatory arthritis (such as rheumatoid arthritis, psoriatic arthritis, spondyloarthritis), a systemic autoimmune rheumatic disease (such as systemic lupus erythematosus, inflammatory myositis, systemic sclerosis, antiphospholipid antibody syndrome, Sjogren syndrome, systemic vasculitis), or another chronic musculoskeletal or rheumatic condition (such as crystal arthritis and osteoarthritis)\n* Currently taking ≥5 regular medications and ≥1 PIM\n* Anticipated ongoing clinical follow-up in rheumatology at an interval of every 3-9 months\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Acute life-threatening illness or life expectancy \\\u003C12 months","60 Years",{"count":199,"type":21},100,"The goal of this prospective observational quality improvement study is to determine if a physician tool, MedSafer, combined with educational brochures for patients, can help to reduce the use of 'potentially inappropriate medications' (PIMs) in adults aged 60 and over with rheumatic conditions and polypharmacy (taking 5 or more regular medications).\n\nResearchers will follow participants during usual rheumatic disease care. They will compare the rate of PIM deprescribing (stopping medications or reducing the dose) before and after the introduction of the following interventions:\n\n* MedSafer reports provided to treating physicians\n* EMPOWER consumer brochures provided to participants\n\nParticipants will complete 4 study visits over 18-20 months during which researchers will collect information on medication changes, serious adverse events (emergency visits or hospitalizations), and quality of life.",[202,203,28,204,205,206],"Rheumatic Diseases","Inflammatory Arthritis","Vasculitis","Muskuloskeletal Diseases","Systemic Autoimmune Diseases",[208,209,202,210],"Deprescribing","Potentially inappropriate medications","Polypharmacy","2026-04-27",{"date":213,"type":39},"2026-05-01",{"date":215,"type":39},"2025-10-29",{"date":217,"type":21},"2028-06-30",{"name":219,"class":75},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":143,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":47},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":147,"type":21},[149],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[152,28,153,154,30,155],[157,153,231,232,30,233],"Systemic Lupus Erthematosus","IgAN - IgA Nephropathy","ANCA-Associated Vasculitis (AAV)","2026-03-30",{"date":236,"type":39},"2026-04-02",{"date":238,"type":21},"2026-04-01",{"date":240,"type":21},"2029-12",{"name":167,"class":75},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":47},"100630763","phase-1-a-phase-1-study-of-hb2198-in-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-sle-100630763","NCT07491900","A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)","A Phase 1, Open Label Dose Escalating Study of HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody With Dual Fc Domains, in Patients With Moderately to Severely Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* • Meet 2019 ACR \u002F 2023 EULAR SLE classification criteria\n\n  * Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)\n  * LN participants: biopsy confirmed active Class III\u002FIV ± V or Class V LN; proteinuria ≥0.8 g\u002Fg; eGFR ≥30 mL\u002Fmin\u002F1.73 m²\n  * ERL participants: inadequate response\u002Fintolerance to ≥1 standard SLE therapy\n  * Positive ANA (≥1:80) or SLE associated autoantibodies\n  * Required minimum lab values (lymphocytes ≥500\u002FµL, B cells ≥25\u002FµL, ANC ≥1000\u002Fmm³, IgG ≥600 mg\u002FdL, etc.)\n  * Women of childbearing potential: negative pregnancy test; contraception required\n  * Voluntary informed consent\n\nExclusion Criteria:\n\n* (Key) Inclusion Criteria:\n\n  * Meet 2019 ACR \u002F 2023 EULAR SLE classification criteria\n  * Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)\n  * LN participants: biopsy confirmed active Class III\u002FIV ± V or Class V LN; proteinuria ≥0.8 g\u002Fg; eGFR ≥30 mL\u002Fmin\u002F1.73 m²\n  * ERL participants: inadequate response\u002Fintolerance to ≥1 standard SLE therapy\n  * Positive ANA (≥1:80) or SLE associated autoantibodies\n  * Required minimum lab values (lymphocytes ≥500\u002FµL, B cells ≥25\u002FµL, ANC ≥1000\u002Fmm³, IgG ≥600 mg\u002FdL, etc.)\n  * Women of childbearing potential: negative pregnancy test; contraception required\n  * Voluntary informed consent\n\n(Key) Exclusion Criteria:\n\n* Anti CD19 or anti CD20 therapy within 6 months\n* Active CNS lupus\n* Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease\n* Active infection or recent serious infection\n* Positive HBV DNA or HCV RNA; HIV infection\n* Major surgery within 4 weeks\n* Prior organ or stem cell transplant\n* Current pregnancy or breastfeeding\n* Recent IVIg or plasmapheresis (\\\u003C3 months)\n* Live vaccine within 30 days\n* Any condition judged unsuitable by Investigator","65 Years",{"count":251,"type":21},30,[24],"This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19\u002FCD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.",[28,61,255],"Extra-renal Lupus (ERL)","2026-03-18",{"date":258,"type":39},"2026-03-25",{"date":260,"type":21},"2026-03-23",{"date":262,"type":21},"2028-10-24",{"name":264,"class":46},"Hinge Bio",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":284,"locationsCount":47},"100616400","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-b-cell-mediated-autoimmune-disease-100616400","NCT07305116","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","Inclusion Criteria:\n\n\\- Common Inclusion Criteria:\n\n1\\. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%. 2. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n\n3\\. Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n\nDisease-Specific Inclusion Criteria\n\nSLE:\n\n1. Age ≥ 5 years.\n2. Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) Treated with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, thalidomide, belimumab, or rituximab) for at least 3 months.\n\n   b) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   c) Patients who cannot taper glucocorticoids to ≤5 mg\u002Fday after 6 months of conventional therapy.\n4. SLE disease activity: SLEDAI-2K score ≥ 8; or SLEDAI ≥ 6 plus at least one BILAG-2004 category A or two category B scores, or both.\n5. No occurrence of macrophage activation syndrome within 1 month prior to screening.\n6. Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n\nMDR-SRNS\n\n1. Age ≥3 years old, gender unlimited.\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n\n   b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n\n   c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n4. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n   a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg; b) \\>50% decline in eGFR within 3 months; c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Scleroderma fulfilling the 2013 ACR classification criteria\n3. Positive scleroderma-related antibodies.\n4. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n5. Must meet at least one of the following adequate treatment conditions:\n\n   1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n   2. Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n   3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n6. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n3. Has received glucocorticoids (≥1 mg\u002Fkg\u002Fday) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, telitacicept, etc.) for at least 3 months without achieving sustained remission, or has experienced relapse after remission;or meets the criteria for severe vasculitis (Appendix 1), with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n4. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n5. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n\n  2\\. Subjects with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n\n  4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n\n  5\\. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n\n  7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n\n  8\\. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or congenital immunodeficiency. 11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n\n  12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n\n  13\\. Received live vaccine within 4 weeks before screening. 14. Tested positive in Blood pregnancy test. 15. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n\n  16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n\n  17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome",{"count":147,"type":21},[24],"CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.",[152,28,153,154,30,155],[277,153,231,232,30,233],"CAR-T","2026-01-31",{"date":280,"type":39},"2026-02-03",{"date":282,"type":39},"2025-12-01",{"date":240,"type":21},{"name":167,"class":75},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100620543","phase-1-kn5501-cell-injection-for-refractory-sleclear-100620543","NCT07358988","KN5501 Cell Injection for Refractory SLE(CLEAR)","A Multicenter Phase I Clinical Study of CD19-Targeted CAR-NK Cell Therapy for Moderate to Severe Active Systemic Lupus Erythematosus in China","CLEAR","Inclusion Criteria:\n\n* 1\\. Aged 18\\~70(including thresholds) when obtaining informed consent;\n* 2\\. Body weight \\> 40.0 kg at screening;\n* 3\\. Refractory SLE patients with moderate to severe activity;\n* 4\\. CBC meeting predefined requirements at screening, including ANC ≥ 1.5×10\\^9\u002FL, Hb ≥ 80g\u002FL, and PLT ≥ 50×10\\^9\u002FL(Not applicable, if it is ITP due to active SLE disease which is judged by investigator);\n* 5\\. Adequate liver, kidney, lung and ;heart function at screening;\n* 6\\. The date of last supportive therapy of hemopoietic growth factor(including EPO, G-CSF, GM-CSF and TPO, etc.)should be at least 2 weeks before screening visit, the last date of PLT infusion should be at least one week before screening visit, and the last date of RBC infusion should be at least 2 weeks before screening visit;\n* 7\\. The number of CD19+ B cells in peripheral blood \\> 5 cells per microliter at screening;\n* 8\\. Negative serum pregnancy test for WOCBPs at screening. Male or Female trial participants of child bearing potential should utilize efficient contraceptive measures from ICF signing until at least one year since the last dose, and promise not to donate ovums or sperms until at least one year since the last dose.\n\nExclusion Criteria:\n\n* 1\\. Hypersensitive or allergic to any components of KN5501(e.g. DEXTRAN 40) or other trial interventions including fludarabine, cyclophosphamide, and tocilizumab, or having ever experienced severe anaphylaxis;\n* 2\\. Severe lupus nephritis patients, defined as proteinuria ≥3.5g\u002F24h or a history of renal replacement therapy. Or high risk of progressive LN disease which will probably require induced intensive treatment;\n* 3\\. CNS affected, including but not limited to lupus encephalopathy, seizure, strock(ischemic or hemorrhagic), dementia, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or mental disease;\n* 4\\. Severe lung disease, e.g. pulmonary hypertension ≥ grade 3(WHO), or requiring mask oxygen therapy or ventilator-assisted breathing(non-invasive or invasive) ;\n* 5\\. Unstable cardiovascular system, e.g. myocardial infarction within 6 months before screening, unstable angina within 3 months before screening, uncontrolled and clinically significant ventricular arrhythmia(including ventricular tachycardia, ventricular fibrillation, or TdP), second-degree atrioventricular block of Mobitz type II or third-degree atrioventricular block, congestive heart failure with New York Heart Association class ≥ 3; poorly controlled hypertension (SBP \\> 160 mmHg and\u002For DBP \\> 100 mmHg), or accompanied by hypertensive crisis or hypertensive encephalopathy;\n* 6\\. Malignancy within 5 years before screening, excluding tumors with negligible risk of metastasis or death that are curable, such as radically treated non-melanoma skin cancer, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smears, and completely resected ductal carcinoma in situ of the breast;\n* 7\\. Severe infections requiring intravenous anti-infection treatment within 14 days before planned lymphodepletion, however preventive therapy is permitted;\n* 8\\. Active or latent tuberculosis at screening;\n* 9\\. HBV or HCV infection at screening. If positve HBsAg and\u002For HBcAb, HBV-DNA should be tested to confirm. If positive HCV-Ab, HCV-RNA should be tested to confirm;\n* 10\\. Active HIV infection history, or positive serum HIV antigen or antibody test, or positive antibody test for Treponema Pallidum at screening.","70 Years",{"count":84,"type":21},[24],"The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE). It will also learn if KN5501 cell injection works to treat refractory SLE. The main questions it aims to answer are:\n\n1. Is KN5501 cell injection safe in adults with SLE? And the maximum tolerated dose?\n2. Does KN5501 cell injection lower the disease activity of SLE in adults with refractory SLE？\n\nParticipants will:\n\nReceive one or multiple (3 to 5 times) intravenous infusion of KN5501 cell injection at inpatient ward after lymphodepletion.\n\nVisit the clinic at predefined frequency (from 1 week interval to 12-16 weeks' interval) for checkups and tests.",[28],"2026-01-13",{"date":300,"type":39},"2026-01-22",{"date":302,"type":21},"2026-01",{"date":304,"type":21},"2027-07",{"name":306,"class":46},"Ruitherapeutics Co., LTD",6,{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":316,"sex":16,"minAge":82,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":47},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",true,{"count":318,"type":21},120,"The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[202,27,321,322,323,324,325,326,30,28,327,328,329],"Giant Cell Arteritis (GCA)","Psoriatic Arthritis (PsA)","Axial Spondylarthritis (axSpA)","Polymyalgia Rheumatica (PMR)","ANCA Associated Vasculitis (AAV)","Connective Tissue Disease (CTD)","Idiopathic Inflammatory Myopathy (IIM)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":332,"type":39},"2025-09-02",{"date":334,"type":39},"2025-04-01",{"date":336,"type":21},"2028-12",{"name":338,"class":75},"University of Bonn"]