[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dermatomyositis-dm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dermatomyositis-dm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,81],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100601482","fast-for-dm---fatty-acid-supplementation-trial-fast-for-dermatomyositis-dm-100601482",false,"NCT07111065","FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)","Phase II, Randomized, Double-Blind, Placebo-Controlled Trial of Omega-3 Fatty Acid (O3FA) Supplementation for Adult and Juvenile Dermatomyositis (DM\u002FJDM)","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Adults 18-60 years of age with probable or definite EULAR ACR Myositis Classification Criteria 2017 for adult or juvenile dermatomyositis (DM, JDM).\n* Willingness to adhere to the general healthy diet pattern regimen, undergo dietary coaching on weekly to biweekly basis (10 sessions), and to complete online random reporting of dietary intake over a 6-month period.\n* Ability and willingness to comply with taking 4 study pills twice a day for 6 months.\n* Ability and willingness to wear ActiGraph device at home for 7 continuous days, twice in the study.\n* Willingness and ability to complete and consent to study testing, including blood, stool, and urine samples, and imaging studies.\n* Ability and willingness to complete a total of 5 study visits (screening, weeks -6, 0, 12, 24) onsite at NIH Clinical Center in Bethesda, Maryland.\n* Has the ability\u002Ftransportation methods to attend on-site visits. Willing to pay for travel and out-of-pocket expenses.\n* Own or have reliable access to a computer, laptop or smart phone device (iPhone or Android) with internet access, and an active email address, to complete study consent form, online questionnaires, telehealth visits, and review online dietary education materials and videos.\n* Ambulatory\n* Must live within the United States.\n* Must be proficient in the English language and complete questionnaires in English (forms validated in English). Ability and willingness to complete forms online.\n* Moderately active DM\u002FJDM defined by:\n\n  * MD global VAS with a \\>= 2.0 cm on a 10 cm scale and maximum value of 7.0 cm, and\n  * At least 2 of the following criteria:\n\n    * Patient Global Disease Activity Assessment \\>= 2 cm out of 10 cm visual analog scale (VAS).\n    * MMT-8 score of \\\u003C=138 out of 150.\n    * Health Assessment Questionnaire disability index with a minimum value of \\>= 0.50 out of 3.0\n    * Elevation of at least one of the muscle enzymes \\[which includes creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), ALT and AST\\] at a minimum level of 1.3X the upper limit of normal.\n    * Global Extramuscular disease activity score with a minimum value of \\>= 1.0 cm on a 10 cm VAS scale (this measure is the physician's composite evaluation and is based on assessments of activity scores on the constitutional, cutaneous, skeletal, gastrointestinal, pulmonary and cardiac scales of the Myositis Disease Activity Assessment Tool (MDAAT).\n* Physician global damage and muscle damage both \\\u003C= 5.0 cm\u002F10 cm VAS\n* If receiving prednisone and methotrexate, the dose must be stable for at least 4 weeks prior to the Week -6 visit, and daily prednisone \\\u003C= 20 mg\u002Fday.\n* Background therapy with other non-corticosteroid immunosuppressive agent, if required, must be at a stable dose for at least 6 weeks prior to the Week -6 visit, except with IVIG regimen should be stable 90 days prior to the Week -6 visit and for rituximab, stable regimen for 4 months prior to Week -6.\n* If an immunosuppressive agent was discontinued prior to the screening visit, then there must be a washout period before week -6 visit:\n\n  * 4-week washout for prednisone, methotrexate, and IV methylprednisolone (IV pulse therapy)\n  * 8-week washout for other immunosuppressive drugs, including azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, cyclophosphamide, colchicine, and hydroxychloroquine\n  * 8-week washout for IVIG\n  * For discontinuation of biologic or targeted drug therapies or dietary supplements, a washout prior to visit 1 (week -6) is required of 4 terminal half-lives.\n\n    * Half-lives of most common biologics and targeted drug therapies used in the treatment of DM\u002FJDM:\n\n      * Etanercept Half-life 70 hours, Waiting period before enrollment (4 Half-lives) 12 days\n      * Adalimumab, Half-life, 14 days, Waiting period before enrollment (4 Half-lives) 60 days\n      * Rituximab, Half-life 32 days, Waiting period before enrollment (4 Half-lives) 130 days\n      * Infliximab, Half-life 9 days, Waiting period before enrollment (4 Half-lives) 36 days\n      * Abatacept, Half-life 17 days, Waiting period before enrollment (4 Half-lives) 68 days\n      * Anakinra, Half-life 6 hours, Waiting period before enrollment (4 Half-lives) 1 day\n      * Tofacitinib, Half-life 3 hours, Waiting period before enrollment (4 Half-lives) 1 day\n      * Baricitinib, Half-life 12hours, Waiting period before enrollment (4 Half-lives) 2 days\n* Negative pregnancy test (urine or blood sample) if born female.\n* Body Mass Index (BMI) \\> 18 and \\\u003C= 35 kg\u002Fm\\^2\n* Fish intake of less than 2 servings per week on average for the past 3 months.\n* Intake of meat products (beef, lamb, pork, venison, rabbit, cow's milk or dairy products) within 2 months of screening visit and of week 0 and have no reaction (no shortness of breath, hives, rash, or diarrhea) within 6 hours of ingestion of these meat products.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Polymyositis; inclusion body myositis; cancer-associated myositis, defined as the diagnosis of myositis within 3 years of the diagnosis of cancer, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.\n* Myositis in overlap with another autoimmune disease will be excluded under the following conditions:\n\n  i. Myositis overlapping with another autoimmune disease that precludes accurate assessment of treatment response (e.g., difficulty assessing muscle strength in a patient with scleroderma and associated myositis).\n\nii. Myositis overlapping with inflammatory bowel disease (IBD), including Crohn's disease, ulcerative colitis, or celiac disease, unless stable and well controlled with no changes in IBD-related medications for at least 3 months prior to enrollment, in which case the patient may be included.\n\niii. Myositis overlapping with autoimmune thyroid disease (e.g., Hashimoto's disease or Graves' disease), unless the thyroid disease is\n\nstable and well controlled with no changes in thyroid-related medications for at least 3 months prior to enrollment, in which case the\n\npatient may be included.\n\n* Drug- or toxin-induced myositis, including known HMG-CoA reductase autoantibody-positive necrotizing myopathy following statin use.\n* Moderate to severely active myositis that would require initiation of another immunosuppressive treatment.\n* Joint disease, severe calcinosis, or other musculoskeletal condition, which precludes the ability to assess\u002Fquantitate muscle strength and function.\n* Concomitant illness that would prevent adequate patient assessment or in the investigators' opinion pose an added risk for study participants. The investigator may consider further evaluation or consultation if clinically indicated prior to study enrollment:\n\n  * Recurrent or chronic infections, including HIV, hepatitis B and C, Epstein Barr virus, active coronavirus infection, active or recurrent gastrointestinal infection (including Helicobacter pylori), active or recurrent skin infections with calcinosis.\n  * Disorders that would preclude accurate assessment of neuromuscular function.\n  * Severe swallowing dysfunction with inability to swallow pills.\n  * Patients with generalized lipodystrophy.\n  * Severe cardiomyopathy or arrhythmias, including atrial fibrillation or atrial flutter, New York Heart Association Classification III or IV for congestive heart failure, severe interstitial lung requiring oxygen therapy, gastrointestinal vasculopathy\u002Fulceration or gastroparesis, renal failure requiring dialysis, that in the investigators' opinion poses an additional risk for study participants.\n  * Subjects with any acute and life-threatening condition unrelated to myositis, such as prior sudden cardiac arrest, acute myocardial infarction, stroke, embolism in last 3 months.\n  * History of malignancy, except basal or squamous cell skin cancer or carcinoma in situ of the cervix if at least 5 years since excision.\n  * Uncontrolled hypertension with average blood pressure \\>= 140\u002F90, requiring a new anti-hypertensive medication in the past 8 weeks.\n  * Psychiatric illness that precludes compliance or neuromuscular assessment, including major psychiatric illness requiring hospitalization within the past year and\u002For has had a change in depression or anxiety prescription medications within the past 3 months (by discretion of study physician).\n  * Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, irritable bowel syndrome, symptomatic gallstones, or other conditions that could affect intestinal fat absorption.\n  * Subjects with clinically diagnosed hepatic disease, including but not limited to hepatitis, steatosis, cirrhosis.\n  * Osteoporotic fracture under therapy for pain control or impacting ambulation.\n  * Serum creatinine \\> 2.0mg\u002Fdl or eGFR less than 50 mL\u002Fmin per 1.73 m\\^2.\n  * Subjects with coagulation or bleeding disorders (such as hemophilia) or receiving anti-platelet or anti-coagulant medications, including daily aspirin, warfarin, or Plavix.\n  * Life-threatening non-myositis illness that would interfere with the patient s ability to complete the study.\n* Known contraindications to O3FAs, excipients or placebo contents (e.g., allergy or known hypersensitivity to that drug or its excipients, including porcine gelatin, allergies to fish or shellfish, tocopherols, glycerin, or corn). Religious or ethical reasons to not consume fish, corn and\u002For porcine (pork) products.\n* Participants with any of the following:\n\n  * Idiopathic anaphylaxis\n  * Alpha-gal reaction\n  * Known food allergies to beef, pork, lamb or other meat products, including cow's milk and dairy products, with a history of shortness of breath, rash, or hives within 6 hours of eating these foods.\n* Currently using O3FAs or consuming EPA\u002FDHA in any form for the past 6 months.\n* Currently taking supplements or medications that affect lipoproteins. For discontinuation of lipoprotein drug therapies or dietary supplements, a washout period prior to visit 1 (week -6) is required of 4 terminal halflives:\n\n  * 4 weeks for Niacin, ezetimibe, fibrates, bile-acid sequestrants, statins, plant sterol supplements;\n  * 8 weeks for fish oil supplements, PCSK9 inhibitors\n* Use of medications or dietary supplements that interact with O3FA per pharmacy evaluation. The patient's current medication list will be evaluated for medications\u002Fsupplements with the potential for significant interactions with O3FA.\n* No antibiotic usage in past 3 months, as well as no usage of anti-virals, antifungals, anti-parasitics in past 3 months (except antimalarials and Paxlovid or other COVID-19 anti-viral therapy allowed).\n\n  \\-- Up to 30% (18 patients) of the total enrolled participants may be on routine prophylactic antibiotic use, given that the dose is stable for at least 4 weeks.\n* Subjects being treated with tamoxifen, estrogens or progestins that have not been stable for \\> 4 weeks.\n* Uncontrolled diabetes with HgbA1C \\> 8 or hospitalization in past 6 months for diabetes.\n* Uncontrolled hyperlipidemia with TC \\> 400 mg\u002FdL, TG \\>150mg\u002FdL.\n* Currently on a weight-loss program\n* Has experienced a weight change (gain or loss) of greater than 15 pounds or greater than 20% in the past 3 months\n* Currently taking a GLP-1 or GIP receptor agonist medication for indications other than weight loss.\n* Current use of medications or dietary supplements for weight or appetite control, including laxatives or diarrheal inhibitors within the past 4 weeks.\n* History of eating disorder.\n* Initiation of an exercise program within 4 weeks of screening visit.\n* Known or suspected history of drug or alcohol abuse within the past 6 months as determined by the medical record or patient interview.\n* Blood donation in the last 6 weeks or planned blood donation during study or requiring regular blood transfusion.\n* Pregnant females or nursing mothers within past 3 months, or those planning to get pregnant during the next 9 months.\n* Low total WBC \\\u003C 2000, platelets \\\u003C 100,000\u002Fmm\\^3; hemoglobin \\\u003C 9.5 gm\u002Fdl.\n* Vitamin D level \\\u003C 20 ng\u002Fml (at screening visit - necessitates addition of supplement and re-screen after minimum of 8 weeks).\n* Subjects with TSH levels greater than 1.5X upper limit of normal or clinical evidence of hypothyroidism (at screening visit- necessitates addition of supplement and re-screen after minimum of 8 weeks).\n* Participants with severe claustrophobia.\n* History of or anticipated poor non-cooperation with study requirements.\n* Participation in another clinical experimental therapeutic study within 30 days of screening visit or during the study.\n* Hospitalization within past 30 days (other than for routine infusions).\n* Prisoners or subjects who are involuntarily incarcerated.\n* Resident of a nursing home, ward of the state, or institutionalized during any part of the study period.\n* Persons with decisional incapacity\u002Fcognitive impairment.\n* Any history or evidence of severe illness or any other condition that would make the patient, in the opinion of the investigator, unsuitable for the study.\n* Participants who do not complete the ASA24 within 7 calendar days of screening will be excluded from the protocol. Additionally, participants will be excluded if their energy intake from the ASA24 is above or below established cut-off values for age and gender based on the 5th and 95th percentile of energy intakes from National Health and Nutrition Examination Survey (NHANES) data. Cut-off values for exclusion are \\\u003C600 kcal or \\>4400 kcal for women and \\\u003C650 kcal and \\>5700 kcal for men.","ALL","18 Years","60 Years",{"count":20,"type":21},3000,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Dermatomyositis (DM) is a rare autoimmune disease that causes muscle weakness, skin rashes, and other symptoms. Researchers think both genetic and environmental factors play a role in this disease. They want to find out more about how diet and lifestyle choices affect people with DM\u002FJDM.\n\nObjective:\n\nTo see if omega-3 fatty acid supplements from fish oil, combined with a healthy diet, can help people with DM\u002FJDM.\n\nEligibility:\n\nAdults 18-60 years old, who live in the United States, can read English, and access Internet to complete questionnaires can participate.\n\nDesign:\n\nParticipants will have 5 or 6 inpatient visits. For 5 visits they may need to stay in the Clinical Center for up to 5 days. Participants will be screened. They will have a physical exam with blood, urine and stool tests. They will have tests of their heart and lung function. Their muscle strength will be measured. They may have an imaging scan of their thighs and pelvis. They will complete online questionnaires about their health and lifestyle. They may complete two optional skin biopsies. Participants will take 4 small capsules by mouth twice a day for up to 6 months. The capsules will contain omega-3 fatty acids from fish oil or a placebo. The placebo looks just like the regular capsule but contains no active ingredients. Participants will not know which capsules they are taking. They will follow a healthy diet based on the General Healthy Eating Pattern.\n\nParticipants will receive dietary coaching and will have virtual check-ins throughout the study. For two 7-day periods, they will wear a watch-like device to track their daily activity and sleep patterns. Participants may opt to remain in the study for an additional 12 weeks. All will receive the fish oil supplements during this stage.",[27,28],"Dermatomyositis (DM)","Juvenile Dermatomyositis (JDM)",[30,31,32,33,34],"Fish oil supplements","Omega-3 Fatty Acid","Clinical Trial","Online questionnaires","Diet Study","RECRUITING","2026-08-20",{"date":38,"type":39},"2026-08-21","ACTUAL",{"date":41,"type":21},"2026-08-26",{"date":43,"type":21},"2031-11-03",{"name":45,"class":46},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":47},"100649075","phase-1-baff-car-t-cells-lmy-922-for-treatment-of-refractory-autoimmune-disease-100649075","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.","16 Years","75 Years",{"count":58,"type":21},94,[60],"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.",[63,64,27,65],"Rheumatoid Arthritis (RA)","Systemic Lupus Erthematosus (SLE)","Systemic Sclerosis (SSc)",[67,68,69],"Systemic Scleroderma","Lupus","Lupus Nephritis","NOT_YET_RECRUITING","2026-07-21",{"date":73,"type":39},"2026-07-28",{"date":75,"type":21},"2026-10",{"date":77,"type":21},"2030-03",{"name":79,"class":80},"Luminary Therapeutics","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100544632","phase-1-phase-1b-trial-of-ray121-in-immunological-diseases-rainbow-trial-100544632","NCT06371417","Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)","Phase 1b Open-label Basket Trial of RAY121 to Inhibit Classical Complement Pathway in Immunological Diseases (RAINBOW Trial)","1. Signed informed consent form\n2. Age ≥ 18 and ≤ 85 at the time of signing informed consent form with Karnofsky score ≥ 60 % at screening\n3. Ability to comply with the study protocol\n4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods\n5. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm\n6. APS cohort: Established primary APS defined by the following criteria (at least one of the laboratory criteria and one of the clinical criteria must be met):\n\n   * Laboratory criteria (aPL profile)\n\n     * Persistently positive LA test\n     * Persistently positive aCL IgG isotype\n     * Persistently positive aβ2GPI IgG isotype\n   * Clinical criteria\n\n     * Livedoid vasculopathy and presence of skin ulcer\n     * Acute\u002Fchronic aPL nephropathy\n7. BP cohort:\n\n1\\) Predominant cutaneous lesions 2) Diagnosis with BP with following assessments positive:\n\n1. Positive direct immunofluorescence, and either\n2. Positive indirect immunofluorescence, or\n3. Positive serology on ELISA for BP180 autoantibody 3) BPDAI score \\>= 20 4) Weekly average of daily Peak Pruritus NRS \\>=4 5) Accept to take photograph of bullous lesions\n\n   8\\. BS cohort:\n   1. Diagnosed with BS\n   2. Oral ulcers that occurred at least 3 times in the previous 12 month period\n   3. Have at least 2 oral ulcers over the 4 weeks prior to screening\n   4. Have at least 2 oral ulcers at Week 0\n   5. Have prior treatment with at least 1 non-biologic BS therapy\n   6. Patients who need systemic therapy as whose oral or mucocutaneous ulcers cannot be adequately controlled by topical therapy\n\n   9\\. DM cohort:\n   1. Diagnosed with definite or probable inflammatory myopathies and categorized as DM\n   2. Patients with inadequate response to corticosteroids and\u002For immune-suppressants or intolerance to DM therapies\n   3. MMT-8 score \\\u003C 142, with at least one abnormality in the following Core Set Measures:\n\n      * PtGA-VAS \\>= 2 cm\n      * PhGA-VAS \\>= 2 cm\n      * Global extra-muscular activity \\>= 2 cm\n      * At least one muscle enzyme \\> 1.5 times ULN\n      * HAQ \\>= 0.25\n   4. Moderate to severe DM defined as CDASI activity score \\> 14\n\n   10\\. IMNM cohort:\n   1. Clinically Diagnosed with IMNM as anti-HMGCR myopathy or anti-SRP myopathy\n   2. CK \\> 1,000 U\u002FL\n   3. Patients who have an inadequate response to corticosteroids and\u002For immunesuppressants or intolerance to IMNM therapies\n   4. MMT-8 score \\\u003C 142\n\n   11\\. ITP cohort:\n   1. Confirmed diagnosis of persistent\u002Fchronic ITP based on the following criteria:\n\n      * ITP defined per the current guidelines\n      * Platelet count \\\u003C= 30 × 10\\^9\u002FL on 2 consecutive occasions\n   2. Lack of an sustained adequate platelet count response to a thrombopoietin receptor agonist and at least one other ITP treatment or a second TPO-RA\n   3. A history of response with an platelet counts increase more than 20 × 10\\^9\u002FL from baseline by at least one prior line of therapy\n\n   Exclusion Criteria:\n   1. History of anaphylaxis or hypersensitivity to a biologic agent\n   2. Active infection requiring systemic antiviral, antibiotics or antifungal\n   3. Planned surgery during the study\n   4. Pregnant or breastfeeding, or intending to become pregnant\n   5. Any serious medical condition or abnormality in clinical laboratory tests that precludes the patient's safe participation in and completion of the study\n   6. Clinically significant ECG abnormalities\n   7. Illicit drug or alcohol abuse\n   8. Clinical diagnosis of autoimmune diseases other than the target disease (except for Sjögren's syndrome in DM and IMNM)\n   9. Positive for hepatitis B surface antigen\n   10. Positive for hepatitis C virus antibody\n   11. Positive for human immunodeficiency virus antibody\n   12. Evidence of current infection with tuberculosis\n   13. History of cancer within 5 years\n   14. Treatment with investigational therapy within 28 days or 5 half-lives\n   15. Previous and current treatment with anti-C1s antibody at any time\n   16. Other complement inhibitors within 3 months\n   17. Patients who receive any treatments which fall into the Prohibited Therapy Criteria\n   18. Patients with an elevated alanine aminotransferase or aspartate aminotransferase \\> 1.5 × ULN in combination with an elevated total bilirubin \\> 1.5 × ULN\n   19. APS cohort:\n\n       * 1\\) APS associated with other systemic autoimmune disease\n       * 2\\) Acute thrombosis (arterial or venous acute thrombosis diagnosis) within 30 days before screening\n       * 3\\) Patients with thrombotic APS without any anticoagulation treatment\n       * 4\\) Treatment with prohibited medications\n   20. BP cohort:\n\n       ・ 1) Initiation of treatment with or increase in the dose of systemic or topical corticosteroid within 2 weeks\n       * 2\\) Current treatment with a drug that may cause or exacerbate BP unless the dose has been stable\n       * 3\\) Initiation of treatment with topical calcineurin inhibitor, or topical phosphodiesterase (PDE) 4 inhibitor within 7 days\n       * 4\\) Treatment with prohibited medications\n   21. BS cohort:\n\n       ・ 1) BS-related active major organ involvement-ocular lesions requiring immunosuppressive therapy, pulmonary (e.g., pulmonary artery aneurysm), vascular (e.g., thrombophlebitis), gastrointestinal (e.g., ulcers along the gastrointestinal tract), and central nervous systems (e.g., meningoencephalitis) manifestations\n       * 2\\) History of venous or arterial thrombosis within 1 year\n       * 3\\) Treatment with prohibited medications\n   22. DM cohort:\n\n       ・ 1) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n       * 2\\) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, IMNM, juvenile DM or drug-induced myopathy\n       * 3\\) Cancer-associated myositis\n       * 4\\) Significant muscle damage\n       * 5\\) Past history of severe Interstitial lung disease flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n       * 6\\) Severe respiratory muscle weakness\n       * 7\\) Severe bulbar palsy\n       * 8\\) Treatment with prohibited medications\n   23. IMNM cohort:\n\n       ・ 1) PhGA-VAS improvement \\>= 3, or clinically relevant improvement between screening and baseline\n\n       ・ 2) Overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis, juvenile DM or druginduced myopathy\n\n       ・ 3) Cancer-associated myositis\n\n       ・ 4) Significant muscle damage\n\n       ・ 5) Past history of severe Interstitial lung disease (ILD) flare, severe non-infectious lung inflammation which required active intervention, or multiple episodes of lung disease\n\n       ・ 6) Severe respiratory muscle weakness\n\n       ・ 7) Severe bulbar palsy\n\n       ・ 8) Treatment with prohibited medications\n   24. ITP cohort:\n\n       ・ 1) Secondary ITP\n\n       ・ 2) Clinical diagnosis or history of Myelodysplastic Syndrome or autoimmune hemolytic anemia\n\n       ・ 3) History of venous or arterial thrombosis within 12 months\n\n       ・ 4) Patients who experienced major bleeding within 4 weeks\n       * 5\\) Treatment with prohibited medications\n       * 6\\) Any laboratory test results meet either of the following criteria at screening:\n\n         * Hemoglobin \\\u003C10 g\u002FdL\n         * Thyroid-stimulating hormone \\>= 10 μIU\u002FmL","85 Years",{"count":90,"type":21},144,[60],"This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).",[94,95,96,27,97,98],"Antiphospholipid Syndrome (APS)","Bullous Pemphigoid (BP)","Behçet's Syndrome (BS)","Immune-mediated Necrotizing Myopathy (IMNM)","Immune Thrombocytopenia (ITP)",{"date":100,"type":39},"2026-07-22",{"date":102,"type":39},"2024-08-19",{"date":104,"type":21},"2027-06-30",{"name":106,"class":80},"Chugai Pharmaceutical",77]