[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sle---systemic-lupus-erythematosus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sle---systemic-lupus-erythematosus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,46,75,107,131,153,176,202,221,243,263,287,310,333],{"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":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644814","early-phase-1-rd06-05-universal-cd19bcma-car-t-for-refractory-pediatric-autoimmune-diseases-100644814",false,"NCT07674147","RD06-05 Universal CD19\u002FBCMA CAR-T for Refractory Pediatric Autoimmune Diseases","A Clinical Study of the Safety, Efficacy, and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases in Children and Adolescents","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent from patient or legal guardian.\n2. Age \\>=5 to \\\u003C20 years, male or female.\n3. Important organ function meeting the following requirements (excluding abnormalities related to autoimmune disease activity): a) Bone marrow: ANC \\>=1.0x10\\^9\u002FL, hemoglobin \\>=60 g\u002FL, platelets \\>=30x10\\^9\u002FL; b) Liver: ALT \\\u003C=3xULN (except IIM-related elevation), AST \\\u003C=3xULN, total bilirubin \\\u003C=2xULN (\\\u003C=3xULN for Gilbert syndrome); c) Kidney: eGFR \\>=30 mL\u002Fmin\u002F1.73m\\^2 (lower eGFR or on renal replacement may be allowed if benefit \\> risk by investigator judgment); d) Cardiac: LVEF \\>=55% by echocardiogram; e) Pulmonary: No severe lung disease, SpO2 \\>=92%.\n4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n5. Females of childbearing potential must use highly effective contraception from at least 28 days before lymphodepletion through 12 months post-infusion. Males must use effective barrier contraception and not donate sperm from start of lymphodepletion through 12 months post-infusion.\n\n   Disease-Specific Inclusion Criteria for SLE\u002FLN:\n6. Diagnosis of SLE by 2019 EULAR\u002FACR or 2012 SLICC criteria.\n7. If renal involvement: kidney biopsy within 2 years showing active nephritis (class III, IV, V, or combination). Renal involvement defined as proteinuria \\>0.15g\u002F24h, or hematuria, or eGFR \\\u003C90.Inadequate response to standard therapy: high-dose glucocorticoid (\\>=1 mg\u002Fkg\u002Fd prednisone equivalent) + hydroxychloroquine + at least 2 DMARDs for 3 months, or intolerance, or unable to taper steroid to \\\u003C=5 mg\u002Fday at 6 months.\n8. Positive ANA, anti-dsDNA, or anti-Smith antibody.\n9. SLEDAI-2K \\>=8 and clinical SLEDAI-2K \\>=4 (renal proteinuria \\>0.5g\u002F24h or UPCR \\>500 mg\u002Fg or active urinary sediment may waive the clinical SLEDAI-2K requirement).\n10. Physician Global Assessment (PGA) \\>=1.0 (0-3 VAS).\n\n    Disease-Specific Inclusion Criteria for SSc:\n11. Diagnosis of SSc by 2013 ACR\u002FEULAR criteria.\n12. Diffuse cutaneous SSc.\n13. Evidence of active disease (e.g., new SSc within 2 years, new skin involvement or worsening mRSS within 6 months, tendon friction rubs, lung function decline, ILD progression).\n14. FVC \\>=50% and DLCO \\>=45% predicted.\n15. Failed or relapsed on conventional therapy (glucocorticoid \\>0.5 mg\u002Fkg\u002Fd prednisone equivalent + at least two immunomodulators for \\>6 months).\n\n    Disease-Specific Inclusion Criteria for IIM:\n16. Diagnosis of IIM (dermatomyositis, antisynthetase syndrome, IMNM) by 2017 ACR\u002FEULAR criteria (probability \\>=55%).\n17. Active disease: at least 2 of 6 core set abnormalities (MMT-8\\\u003C142, PhGA \\>=2 cm, PtGA \\>=2 cm, extra-muscular MDAAT \\>=2 cm, PedsQL \\>=60, CK \\>=1.5xULN).\n18. Positive myositis-specific autoantibody.\n19. Failed or relapsed on conventional therapy (glucocorticoid \\>1 mg\u002Fkg\u002Fd prednisone equivalent + at least 2 immunomodulators for \\>=6 months).\n\n    Disease-Specific Inclusion Criteria for IgAN:\n20. Biopsy-confirmed IgA nephropathy.\n21. On ACEi\u002FARB for \\>=3 months, and at least one of: a) proteinuria \\>=500 mg\u002F24h or UPCR \\>=0.5 mg\u002Fmg after \\>=3 months of steroid + at least one immunosuppressant\u002Fbiologic; b) eGFR decline \\>50% within 3 months; c) 22.intolerance to conventional therapy with benefit \\> risk.\n\nDisease-Specific Inclusion Criteria for MDR-NS:\n\n23.Meets 2025 KDIGO definition of steroid-resistant nephrotic syndrome. 24.At least one of: a) failed to achieve remission after 12 months of two different mechanism steroid-sparing agents (at least one calcineurin inhibitor); b) no remission after 3-6 months of one CNI with benefit \\> risk; c) intolerance to conventional therapy; d) coexisting systemic disease requiring long-term immunosuppression.\n\n25.Prior kidney biopsy showing minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS).\n\nExclusion Criteria:\n\n1. Co-existing autoimmune disease that may interfere with disease activity attribution or add safety risk (unless stable \\>=3 months and approved).\n2. Prior B-cell\u002FASC depletion therapy: a) Anti-CD20 or T-cell engager within 3 months (allowed if \\>3-6 months and CD19+ B-cells \\> LLN); b) Prior CD19 and BCMA dual-targeted therapy, or CD19 or BCMA targeted therapy within 6 months (allowed if \\>6 months and B-cells \\> LLN); c) Other B-cell\u002FASC targeted therapies require approval.\n3. Rapidly progressive glomerulonephritis (RPGN): \\>=50% crescents on biopsy, or doubling of serum creatinine within 2 months, or investigator judgment.\n4. Cardiac disease: NYHA class III\u002FIV heart failure, MI, angioplasty\u002Fstent, unstable angina, or other severe cardiac disease within 12 months.\n5. Severe CNS disease (traumatic brain injury, impaired consciousness, epilepsy, cerebrovascular ischemia\u002Fhemorrhage) that may affect compliance or assessment.\n6. Malignancy history except cured non-melanoma skin cancer or carcinoma in situ, unless disease-free for \\>=3 years.\n7. Primary immunodeficiency.\n8. Uncontrolled infection (simple UTI or upper respiratory infection allowed).\n9. Known history of HIV, hepatitis C, or syphilis infection.\n10. Active or latent hepatitis B infection.\n11. Positive EBV or CMV DNA or IgM at screening.\n12. History of recurrent tuberculosis.\n13. Prior CAR-T or other transgenic immune cell therapy.\n14. Live attenuated vaccine within 4 weeks before enrollment.\n15. Allergy to any component of the cell therapy product.\n16. Hypersensitivity to tacrolimus or prior grade \\>=3 tacrolimus-related toxicity requiring hospitalization (exceptions may be approved).\n17. Participation in another clinical trial within 30 days before screening.\n18. Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n19. Any other condition judged by investigator as unsuitable for study.\n\n    Disease-Specific Exclusion Criteria for SLE:\n20. Active\u002Funstable neuropsychiatric lupus (seizures, psychosis, organic brain syndrome, CVA, encephalitis, CNS vasculitis) within 90 days requiring intervention.\n21. Prior treatments: belimumab\u002Ftelitacicept within 4 weeks; ianalumab within 8 weeks unless B-cells \\> LLN; \\>1 systemic NSAID within 14 days; inability to wash out NSAID before disease activity assessment; intra-articular\u002FIM glucocorticoid within 6 weeks; immunosuppressant doses above specified limits; initiation or dose change of hydroxychloroquine within 8 weeks; ACEi\u002FARB\u002FSGLT2 inhibitor dose change within 4 weeks.\n22. Disease flare requiring increased corticosteroids (\\>20 mg\u002Fday prednisone equivalent) or new immunosuppression during screening.\n\n    Disease-Specific Exclusion Criteria for IIM:\n23. Severe rhabdomyolysis or CK \\>=20xULN.\n24. FVC \\\u003C=60% predicted, or DLCO \\\u003C=70% predicted, or worsening lung function compared to prior 3-12 months.\n\n    Disease-Specific Exclusion Criteria for SSc:\n25. Anti-centromere antibody positive without ATA or anti-RNAP3.\n26. Clinically significant respiratory disease other than ILD (severe COPD, severe asthma, recent severe respiratory infection, smoking).\n27. FVC \\\u003C50% or DLCO \\\u003C40% predicted.\n28. On lung transplant list or expected within 12 months.\n29. History of scleroderma renal crisis within 6 months.\n30. SSc-like disorders (morphea, eosinophilic fasciitis, etc.).\n31. Antifibrotic drugs within 4 weeks (colchicine, D-penicillamine, pirfenidone, tyrosine kinase inhibitors).\n32. Prior chlorambucil, bone marrow transplant, or total lymphoid irradiation.\n\n    Disease-Specific Exclusion Criteria for IgAN:\n33. Secondary IgAN (cirrhosis, celiac disease, HIV, malignancy).\n34. Other cause of chronic kidney disease (diabetic nephropathy, other primary glomerulopathy) that may interfere.\n35. Uncontrolled blood pressure.\n36. Prior treatments: hydroxychloroquine dose change within 8 weeks; biologics (infliximab, eculizumab, canakinumab) within 4 weeks; prednisone \\>30 mg\u002Fday or unstable dose; endothelin receptor antagonist within 4 weeks before lymphodepletion.\n\n    Disease-Specific Exclusion Criteria for MDR-NS:\n37. Secondary nephrotic syndrome\u002Fproteinuria (infection-related, drug-related, systemic disease) that may interfere.\n38. On maintenance dialysis, need for immediate renal replacement, or expected dialysis\u002Ftransplant within 12 months.\n39. Prior treatments: ACEi\u002FARB dose change within 4 weeks; glucocorticoid dose adjustment within 2 weeks or need for \\>10 mg\u002Fday prednisone equivalent; 40.disease flare requiring increased steroids (\\>10 mg\u002Fday) or new immunosuppression during screening.","ALL","5 Years","20 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19\u002FBCMA dual-targeting chimeric antigen receptor T-cell (CAR-T), in pediatric and adolescent patients with refractory autoimmune diseases, including systemic lupus erythematosus\u002Flupus nephritis (SLE\u002FLN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), multidrug-resistant nephrotic syndrome (MDR-NS), and refractory IgA nephropathy (IgAN).\n\nApproximately 30 eligible patients will be enrolled and receive a single intravenous infusion of RD06-05 at an initial dose of 6×10⁶ CAR+ T cells\u002Fkg, with a potential dose escalation to 10×10⁶ CAR+ T cells\u002Fkg following review by a Safety Review Committee (SRC).",[27,28,29,30,31,32],"Autoimmune Diseases","SLE - Systemic Lupus Erythematosus","SSc-Systemic Sclerosis","IIM- Idiopathic Inflammatory Myopathies","IgAN - IgA Nephropathy","Multi-Drug Resistant Nephrotic Syndrome","NOT_YET_RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-29","ACTUAL",{"date":39,"type":21},"2026-07",{"date":41,"type":21},"2030-07",{"name":43,"class":44},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100640182","early-phase-1-cd19bcma-targeted-universal-car-t-cell-injection-for-the-treatment-of-autoimmune-diseases-100640182","NCT07596680","CD19\u002FBCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases","Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection in Patients With Autoantibody-Mediated Autoimmune Diseases","Inclusion Criteria\n\n1. General Inclusion Criteria (All Patients)\n\n   1. Voluntarily provides written informed consent.\n   2. Age ≥18 and ≤70 years, any gender.\n   3. Adequate organ function:\n\n      * ALT and AST ≤3×ULN; total bilirubin ≤2×ULN (excluding Gilbert syndrome).\n      * Creatinine ≤1.5×ULN or creatinine clearance ≥40 mL\u002Fmin.\n      * Neutrophils ≥1×10⁹\u002FL; hemoglobin ≥60 g\u002FL; platelets ≥20×10⁹\u002FL; lymphocytes \\>0.3×10⁹\u002FL.\n      * INR ≤1.5×ULN or PT ≤1.5×ULN.\n      * Resting room-air SpO₂ ≥92%.\n      * LVEF ≥50% on echocardiogram.\n   4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n   5. Highly effective contraception required from 28 days before lymphodepletion until 12 months after RD06-05 infusion for females; effective barrier contraception required from lymphodepletion until 12 months after RD06-05 infusion for males, with no sperm donation during the study.\n2. For SLE Patients\n\n   1. Diagnosis of SLE per 2019 EULAR\u002FACR or 2012 SLICC criteria.\n   2. Active disease despite ≥2 months of stable (≥2 weeks) treatment with glucocorticoids plus immunosuppressants and\u002For biologics; prednisone ≥7.5 mg\u002Fday or equivalent.\n   3. Positive ANA, anti-dsDNA antibody, and\u002For anti-Smith antibody at screening.\n   4. SLEDAI-2K \\>6 and clinical SLEDAI-2K ≥4 at screening. Patients with lupus nephritis (proteinuria \\>0.5 g\u002F24h, UPCR \\>500 mg\u002Fg, or active urinary sediment) are exempt from clinical SLEDAI-2K requirement.\n   5. Physician Global Assessment (PGA) ≥1.0 (0-3 VAS) at screening.\n3. For SSc Patients\n\n   1. Diagnosis of SSc per 2013 ACR\u002FEULAR criteria.\n   2. Diffuse cutaneous SSc at screening.\n   3. Active disease defined by at least one of: new SSc within 2 years; new\u002Fworsening skin or thoracic\u002Fabdominal involvement within 6 months; worsening skin thickening (mRSS ≥2); tendon friction rubs within 3 months; worsening respiratory symptoms with FVC decline ≥5% predicted or DLCO decline ≥10% predicted; or ILD progression on HRCT compared to 12 months prior.\n   4. Refractory or relapsing disease after \\>6 months of conventional therapy including glucocorticoids, cyclophosphamide, immunosuppressants, and\u002For biologics.\n4. For AAV Patients\n\n   1. Diagnosis of ANCA-associated vasculitis (MPA, GPA, EGPA) per 2022 ACR\u002FEULAR criteria.\n   2. Positive MPO-ANCA or PR3-ANCA.\n   3. BVAS with at least 1 major item, 3 minor items, or 2 renal items.\n   4. Failure of standard of care: no remission after ≥4 months of glucocorticoids plus cyclophosphamide\u002Frituximab; relapse after prior remission; or persistent active disease despite ≥6 months of SOC.\n5. For IIM Patients\n\n   1. Diagnosis of IIM (DM, ASS, IMNM) per 2017 ACR\u002FEULAR criteria (probability ≥55%).\n   2. Active disease defined by ≥2 abnormal core measures, or active myositis on muscle MRI, or active inflammation on muscle biopsy within 16 weeks.\n   3. Positive myositis-specific autoantibodies.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n6. For pSS Patients\n\n   1. Diagnosis of primary Sjögren's syndrome per 2016 ACR\u002FEULAR criteria.\n   2. Positive anti-SSA\u002FRo antibody.\n   3. ESSDAI ≥6 at screening.\n   4. Refractory or relapsing disease after ≥6 months of conventional therapy including glucocorticoids, immunosuppressants, and\u002For biologics.\n\nExclusion Criteria:\n\n1. General Exclusion Criteria (All Patients):\n\n   1. Coexisting autoimmune disease confounding disease activity\u002Fsafety (stable ≥3 months may be eligible with approval).\n   2. Anti-CD20 mAb\u002FT-cell engager within 3 months; CD19\u002FBCMA-targeted therapy within 6 months (exception with CD19⁺ B-cell \\> LLN and approval).\n   3. Rapidly progressive glomerulonephritis (RPGN).\n   4. NYHA III\u002FIV heart failure; severe cardiac disease within 12 months.\n   5. Severe CNS disease impairing compliance\u002Fassessments.\n   6. Malignancy history (except cured non-melanoma skin cancer\u002Fcarcinoma in situ, disease-free ≥3 years).\n   7. Primary immunodeficiency.\n   8. Uncontrolled infection (uncomplicated UTI\u002Fupper respiratory infection permitted).\n   9. Positive HIV; positive HCV (except undetectable RNA); positive syphilis.\n   10. Positive HBsAg; positive HBcAb (except undetectable HBV DNA).\n   11. Positive EBV\u002FCMV DNA\u002FIgM at screening.\n   12. Active\u002Frecurrent tuberculosis.\n   13. Prior CAR-T or genetically modified immune cell therapy.\n   14. Live attenuated vaccine within 4 weeks before enrollment.\n   15. Hypersensitivity to cell therapy product components.\n   16. Tacrolimus hypersensitivity or ≥Grade 3 toxicity requiring hospitalization.\n   17. Other clinical trial participation within 30 days before screening.\n   18. Pregnant\u002Fbreastfeeding; childbearing potential unwilling to use effective contraception.\n   19. Any other ineligible condition (investigator judgment).\n2. Exclusion Criteria for SLE\n\n   1. Active\u002Funstable neuropsychiatric SLE requiring intervention within 90 days.\n   2. Anti-BAFF\u002FAPRIL therapy within required washout period; multiple NSAIDs within 14 days; inability to hold NSAIDs; intra-articular glucocorticoids within 6 weeks; immunosuppressants exceeding dose limits; hydroxychloroquine dose adjustment within 8 weeks; ACEI\u002FARB\u002FSGLT2i adjustment within 4 weeks.\n3. Exclusion Criteria for AAV\n\n   1. Alveolar hemorrhage requiring invasive ventilation beyond screening.\n   2. Dialysis\u002Fplasmapheresis within 12 weeks.\n   3. Renal transplantation history.\n   4. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   5. High-dose IV glucocorticoids within 4 weeks.\n   6. Oral glucocorticoids \\>60mg prednisone equivalent daily for \\>6 weeks.\n   7. Specific immunosuppressants\u002Fbiologics within 4 weeks.\n   8. Concomitant strong CYP3A4 inducers.\n4. Exclusion Criteria for IIM\n\n   1. Severe rhabdomyolysis or CK ≥120×ULN at screening.\n   2. FVC ≤50% predicted or DLCO ≤40% predicted at screening.\n5. Exclusion Criteria for SSc\n\n   1. Significant respiratory disease other than ILD.\n   2. FVC \\\u003C50% or DLCO \\\u003C40% predicted at screening\u002Fbaseline.\n   3. Lung transplantation listing\u002Fexpected within 12 months.\n   4. Scleroderma renal crisis within 6 months.\n   5. Scleroderma-like disorders.\n   6. Prior chlorambucil, bone marrow transplantation, or total lymphoid irradiation.\n6. Exclusion Criteria for pSS\n\n   1. Active fibromyalgia interfering with assessment\u002Frequiring medication adjustment (stable permitted).\n   2. Cyclophosphamide within 12 weeks; immunosuppressant discontinuation required 1 week before lymphodepletion.\n   3. High-dose glucocorticoids (≥60mg\u002Fday) within 4 weeks.","18 Years","70 Years",{"count":20,"type":21},[24],"This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune diseases. The enrolled population consists of patients with active autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM), Sjögren's syndrome (SS), among others.\n\nThe CAR-T cell dose used in this study is 6×10⁶ CAR⁺ T cells\u002Fkg. Six subjects will be enrolled for each indication, with a total of 30 subjects to be enrolled.",[28,59,60,61,62],"Systemic Sclerosis","ANCA Associated Vasculitis","Idiopathic Inflammatory Myopathies","Sjögren Syndrome",[64],"CD19\u002FBCMA CAR-T","2026-05-12",{"date":67,"type":37},"2026-05-19",{"date":69,"type":21},"2026-04-30",{"date":71,"type":21},"2029-04-30",{"name":73,"class":74},"Nanjing Bioheng Biotech Co., Ltd.","INDUSTRY",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":54,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100636836","phase-2-a-phase-2-open-label-single-arm-trial-of-ft819-in-participants-with-lupus-nephritis-100636836","NCT07570862","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)","RECLAIM-LN","INCLUSION CRITERIA:\n\n* Age ≥12 to ≤70 years\n* Diagnosis of SLE per EULAR\u002FACR 2019 classification criteria\n* Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003\u002F2018 ISN\u002FRPS classification\n* Positivity for at least one of the following autoantibodies at screening:\n\n  1. Antinuclear antibody (ANA)\n  2. Anti-double-stranded DNA (anti-dsDNA) or\n  3. Anti-Smith antibody\n* Active disease, defined as:\n\n  a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g\u002Fg; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible\n* Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN\n\nEXCLUSION CRITERIA:\n\n* Evidence of inadequate organ function during the screening period\n* Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention\n* History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity\n* Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention\n* Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant\n* History of malignancy in the prior 5 years\n* Known allergy to the following FT819 components: albumin (human) or DMSO\n* History of intolerance or contraindication to bendamustine\n* Body weight \\\u003C30 kg\n* Any medical condition, clinical laboratory abnormality, or nonmedical\u002Fsocial issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results","12 Years",{"count":85,"type":21},53,[87],"PHASE2","The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.",[90,91,28,92,93],"Lupus Nephritis","Systemic Lupus Erythematosus","Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV",[95,96,97,98,90,91],"FT819","Fate Therapeutics","Allogeneic CAR T","CD19 - targeted therapy","2026-05-07",{"date":101,"type":37},"2026-05-11",{"date":103,"type":21},"2026-07-01",{"date":105,"type":21},"2030-01-31",{"name":96,"class":74},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100607842","early-phase-1-a-study-of-cc312-for-relapsedrefractory-autoimmune-diseases-100607842","NCT07193810","A Study of CC312 for Relapsed\u002FRefractory Autoimmune Diseases","Exploratory Clinical Study on the Safety and Preliminary Efficacy of CC312 in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.\n* Aged 18-65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.\n* For Systemic Lupus Erythematosus (SLE):\n\n  1. Diagnosed with SLE according to the 2019 EULAR\u002FACR classification criteria；\n  2. Meet at least one of the following: positive antinuclear antibody (ANA) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening；\n  3. Had an inadequate response or relapse after standard therapy, defined as any of the following (alone or combined): glucocorticoids, antimalarials (hydroxychloroquine), immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, cyclosporine, azathioprine), or biologics (rituximab, belimumab, telitacicept). Each regimen must have been administered for ≥3 months, and the subject must have received ≥2 immunosuppressants and\u002For biologics；\n  4. At screening, meet SLEDAI-2000 ≥7 and have at least one BILAG A or two BILAG B organ domain scores；\n  5. Prior to the first dose, subjects must have received glucocorticoids and\u002For antimalarials and\u002For immunosuppressants for ≥12 weeks, with stable doses for ≥30 days；\n  6. If receiving oral glucocorticoids (e.g., prednisone), the dose must be ≤40 mg\u002Fday at screening and during the screening period；\n  7. If using glucocorticoids alone, the dose must be ≥7.5 mg\u002Fday prednisone (or equivalent).\n* For Idiopathic Inflammatory Myopathy (IIM):\n\n  1. Diagnosed with possible or definite IIM per the 2017 EULAR\u002FACR classification criteria (≥5.5 points without biopsy; ≥6.7 points with biopsy) ；\n  2. Have at least one positive myositis-specific autoantibody (MSA) , myositis-associated autoantibody (MAA), or ANA at or prior to screening；\n  3. Had an inadequate response or relapse after conventional therapy, defined as glucocorticoids (prednisone \\>1 mg\u002Fkg\u002Fday or equivalent) and ≥1 immunomodulatory drug (immunosuppressants: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine; biologics: rituximab, belimumab; small molecules: tofacitinib), each for ≥3 months；\n  4. Have active IIM at screening, defined as meeting ≥3 of MMT-8 total score ≤141\u002F150 with ≥20% strength loss in affected muscles; Physician global activity ≥2; Patient global activity ≥2; myositis disease activity assessment tool (MDAAT) ≥2; ≥2 muscle enzymes elevated, with one ≥1.5× upper limit of normal (ULN); health assessment questionnaire (HAQ) ≥0.25；\n  5. Prior to the first dose, subjects must have received glucocorticoids and\u002For immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. Glucocorticoid dose must be ≤60 mg\u002Fday prednisone during screening；\n  6. If a subject is receiving oral glucocorticoids alone, the dose should be at least 7.5 mg\u002Fday of prednisone (or an equivalent dose of other glucocorticoids).\n* For Systemic Sclerosis (SSc):\n\n  1. Diagnosed with diffuse cutaneous SSc per the 2013 EULAR\u002FACR criteria ；\n  2. Have positive ANA and\u002For SSc-related antibodies；\n  3. Disease duration ≤5 years (from initial diagnosis)；\n  4. Had an inadequate response or relapse after conventional therapy. Conventional therapy is defined as treatment with glucocorticoids plus any of the following immunomodulatory agents: cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, tacrolimus, cyclosporine, and\u002For biologics (such as rituximab and belimumab), with a cumulative treatment duration of \\>6 months；\n  5. Modified Rodnan Skin Score (mRSS) ≥15 and ≤30 at screening with progression within 6 months；\n  6. Prior to the first dose, subjects must have received glucocorticoids and\u002For immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. The glucocorticoid dose during the screening period should not exceed 10 mg\u002Fday of prednisone (or an equivalent dose of other glucocorticoids).\n* Females of childbearing potential must use highly effective contraception from screening until 6 months after the last dose, refrain from oocyte donation, and ensure male partners use effective contraception.\n* Males of childbearing potential must use effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation, and ensure female partners use effective contraception.\n\nExclusion Criteria:\n\n* Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \\>6 g\u002F24 h, serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), requirement of prohibited medications for active nephritis per protocol, need for hemodialysis, or receipt of prednisone ≥100 mg\u002Fday (or equivalent glucocorticoids) for ≥14 days.\n* Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis) within 8 weeks prior to screening.\n* Other types of idiopathic inflammatory myopathies: inclusion body myositis, amyotrophic diabetes, or juvenile myositis; patients with severe muscle damage or permanent weakness\u002Fcardiac involvement due to non-IIM causes (e.g., stroke).\n* SSc-related pulmonary hypertension requiring treatment; rapidly progressive SSc-related lower gastrointestinal (small\u002Flarge intestine) involvement requiring parenteral nutrition; active gastric antral vascular ectasia; history of SSc-related renal crisis.\n* History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Other concurrent autoimmune diseases requiring systemic therapy.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Abnormal laboratory findings at screening: Liver function: AST\u002FALT \\>2× upper limit of normal (ULN) (except for IIM patients with elevated muscle enzymes); Hematology: hemoglobin \\\u003C85 g\u002FL, white blood cell count \\\u003C2.5×10⁹\u002FL, platelet count \\\u003C50×10⁹\u002FL.\n* Participation in any other clinical trial (including cell or gene therapy) within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).\n* Received CAR-T therapy within 6 months prior to screening.\n* Treatment with B-cell-depleting agents (e.g., rituximab, or therapies targeting CD19\u002FCD20\u002FBAFF) within 1 month prior to screening, unless B-cell levels returned to pre-treatment or normal ranges.\n* Received non-standard anti-SLE therapies (e.g., Saphnelo) within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening.\n* Received live\u002Fattenuated vaccination within 4 weeks prior to screening or plans to receive such during the trial.\n* Active severe infection requiring antibiotic treatment within 14 days prior to screening.\n* History of Grade 3-4 allergic reaction (per CTCAE v5.0) to another monoclonal antibody, or known hypersensitivity to any component of CC312 (e.g., recombinant proteins, polysorbate 80). Patients with transient (≤24 h) Grade ≤3 reactions may be included after discussion with the investigator.\n* Evidence of drug abuse, substance abuse, or alcohol addiction.\n* Major surgery within 4 weeks or minor surgery within 2 weeks prior to screening; wounds must be fully healed (procedures like catheter placement are excluded).\n* History of cardiovascular events within 6 months prior to screening: New York Heart Association (NYHA) Class III\u002FIV heart failure, myocardial infarction, unstable angina, uncontrolled\u002Fsymptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac conditions.\n* Any other severe underlying disease (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, GI bleeding, severe coagulation disorders), psychiatric disorder, or social circumstances that may interfere with trial conduct, compliance, or pose high risk per investigator's judgment.\n* Concurrent malignancy diagnosed within \\\u003C5 years prior to screening.\n* Pregnant or lactating women.\n* Positive serology for Human Immunodeficiency Virus (HIV) antibody, Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) antibody, or Treponema pallidum (TP) antibody at screening.\n* Active or latent tuberculosis at screening (positive TB-IGRA test).\n* Any other condition deemed ineligible by the investigator.","65 Years",{"count":116,"type":21},6,[24],"This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.",[28,30,29],"RECRUITING","2026-04-09",{"date":123,"type":37},"2026-04-14",{"date":125,"type":37},"2025-09-23",{"date":127,"type":21},"2027-09-29",{"name":129,"class":74},"CytoCares Inc",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100630105","phase-1-iaso-782-in-systemic-lupus-erythematosus-100630105","NCT07483346","IASO-782 in Systemic Lupus Erythematosus","A Phase Ib Study to the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of IASO-782 in Patient With Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Aged 18 to 75 years;\n2. Clinically confirmed diagnosis of SLE before screening;\n3. Currently receiving standard treatment regimens, including any single drug or combination of drugs;\n4. Organ function or laboratory test is basically normal;\n5. Subjects with potential fertility and their partners must use effective contraceptive measures for at least 2 weeks before the first dose of the study drug, throughout the study period, and for 6 months after the end of the study (or early termination of the study);\n6. Females with potential fertility must have a negative pregnancy test during the Screening Phase;\n7. Voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of other primary malignant neoplasm within 5 years of screening;\n2. A history of cardiac disease within the recent 3 months, including New York Heart Association (NYHA) Class III\u002FIV congestive heart failure and cardiac arrhythmias requiring drug treatment;\n3. Subjects with poorly controlled hypertension despite drug treatment;\n4. A history of hypersensitivity to any component of the study drug or its excipients confirmed before screening;\n5. Presence of active infection requiring intravenous drug treatment within 30 days before screening;\n6. Pregnant or lactating females;\n7. Participation in any other clinical trial within 28 days before randomization or within 5 half-lives of the study drug in the other trial (whichever is longer);\n8. Previous treatment drugs have not been adequately washed out;\n9. A previous history of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history suggesting thrombophilia; or any of the following: cardiac arrhythmias known to increase the risk of thrombotic events (e.g., atrial fibrillation), or a corrected QT interval (QTc) \\>450 msec in the subject; or a history of other coagulation abnormalities;\n10. Confirmed diagnosis of severe lupus nephritis within 8 weeks before screening (defined as urine protein \\>6 g\u002F24 hours or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), or requiring treatment with study-prohibited drugs, or having active nephritis requiring prednisone ≥100 mg\u002Fday or equivalent glucocorticoid for ≥14 days; active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis or acute confusional state, cerebrovascular accident, demyelinating syndrome, cranial nerve palsy, or evidence of active central nervous system vasculitis within 12 weeks before the screening visit;\n11. Hepatitis B virus (HBV) infection during the Screening Phase (if HBsAg is positive, or HBsAg is negative but anti-HBc is positive, HBV-DNA testing is required, and the subject will be excluded if viral replication is indicated); positive anti-hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive specific treponema pallidum antibody with positive rapid plasma reagin test;\n12. Tuberculosis (TB) infection: TB testing will be appropriately performed during screening according to local clinical practice. Subjects with active tuberculosis will be excluded, except for those with latent TB who are judged by the investigator to be eligible for the study;\n13. A history of substance abuse or mental disorders;\n14. Any other medical history or condition judged by the investigator to be unsuitable for study participation.","75 Years",{"count":140,"type":21},20,[142],"PHASE1","his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.",[28],"2026-03-16",{"date":147,"type":37},"2026-03-19",{"date":69,"type":21},{"date":150,"type":21},"2028-05-31",{"name":152,"class":74},"Shanghai IASO Biotechnology Co., Ltd",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":157,"conditions":163,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":130},"100617166","phase-1-car-t-cell-therapy-targeting-cd19-and-bcmaqt-019c-in-patients-with-relapserefractory-autoimmune-diseases-100617166","NCT07315087","CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse\u002FRefractory Autoimmune Diseases","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\nCommon Inclusion Criteria:\n\n1. Age ≥ 18 years old (inclusive), regardless of gender.\n2. Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109\u002FL (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g\u002FL; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30mL\u002Fminute (calculated by Cockcroft\u002FGault formula, acute CrCl decrease due to the target disease is excluded; LN is excluded).\n3. Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative human chorionic gonadotropin (hCG) test within 7 days before study enrollment and not be lactating.\n4. Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nDisease-Specific Inclusion Criteria:\n\nRefractory\u002FRelapsed Systemic Lupus Erythematosus:\n\n1. SLE meeting the 2019 American College of Rheumatology (ACR) \u002FEuropean League Against Rheumatism (EULAR) and classification criteria.\n2. Disease activity score SLEDAI-2000 ≥ 8; or with significant organ involvement, such as lupus nephritis (histologically confirmed active nephritis of class III or IV, with or without class V, with an NIH activity index \\> 2, evidence of increased chronicity index; urine protein-to-creatinine ratio \\> 1.0 g\u002Fg, or 24-hour urinary protein \\> 1.0 g).\n3. Definition of refractory or relapsing disease: lack of response after more than 6 months of conventional therapy, or recurrence of disease activity after remission. Conventional therapy is defined as treatment with glucocorticoids in combination with one or more of the following immunomodulatory agents: cyclophosphamide, antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics such as rituximab, belimumab, and telitacicept.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Scleroderma fulfilling the 2013 ACR classification criteria.\n2. Positive scleroderma-related antibodies.\n3. Presence of diffuse cutaneous sclerosis or active interstitial lung disease (high-resolution computed tomography (HRCT) showing ground-glass opacities).\n4. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n5. Definition of progressive: Rapid skin progression (mRSS increase \\> 25%); or progression of lung disease (forced vital capacity (FVC) decrease by 10%, or FVC decrease by more than 5% with diffusing capacity of the lung for carbon monoxide (DLCO) decrease by 15%).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRefractory\u002FRelapsed\u002FProgressive Inflammatory Myopathy:\n\n1. Inflammatory myopathy fulfilling the 2017 EULAR\u002FACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).\n2. Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), or extramuscular disease activity score ≥ 2; Health Assessment Questionnaire (HAQ) total score ≥ 0.25; muscle enzyme levels ≥ 1.5×ULN);\n3. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids , and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n4. Definition of progressive: Rapid progression of interstitial lung disease within a short period.\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. ANCA-Associated Vasculitis fulfilling 2022 ACR\u002FEULAR criteria, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Positive ANCA-associated antibodies (MPO-ANCA or PR3-ANCA positive).\n3. The Birmingham Vasculitis Activity Scale (BVAS) ≥ 15 points (a total score of 63 points), indicating active vasculitis.\n4. Definition of refractory\u002Frelapsed: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission., or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids and any one or more of the following immunomodulatory drugs: cyclophosphamide, antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n\nRefractory\u002FRelapsed Connective Tissue Disease-associated thrombocytopenia:\n\n1. Diagnosis of connective tissue disease established according to the latest classification criteria, including but not limited to systemic lupus erythematosus, primary Sjögren's syndrome, antiphospholipid syndrome, and undifferentiated connective tissue disease.\n2. Confirmed diagnosis of connective tissue disease-associated thrombocytopenia, with platelet count \\\u003C30 × 10\\^9\u002FL, or \\\u003C50 × 10\\^9\u002FL accompanied by a bleeding tendency.\n3. Bone marrow morphology consistent with immune thrombocytopenia.\n4. Prior treatment with at least one course of corticosteroid pulse therapy, or high-dose corticosteroids in combination with one or more immunosuppressants (including biologics) for at least 3 months, without achieving partial remission, or inability to maintain efficacy during steroid tapering.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe drug allergies or allergic tendencies.\n2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.\n3. Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis).\n4. Subjects with insufficient cardiac function.\n5. Subjects with congenital immunoglobulin deficiencies.\n6. History of malignancy within five years.\n7. Subjects with end-stage renal failure(LN is excluded).\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \\>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing.\n9. Subjects with psychiatric disorders and severe cognitive impairments.\n10. Subjects who have participated in other clinical trials within the past 3 months prior to enrollment.\n11. Subjects who have received immunosuppressive agents or biologics with therapeutic effects for indications within 5 half-life prior to enrollment.\n12. Pregnant women or women planning to conceive.\n13. Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.",{"count":161,"type":21},12,[142],[28,29,30,164,165,166],"ANCA Associated Vasculitis (AAV)","Connective Tissue Disease-Associated Thrombocytopenia","SLE-ITP","2026-01-15",{"date":169,"type":37},"2026-01-20",{"date":171,"type":21},"2026-01-01",{"date":173,"type":21},"2029-01-18",{"name":175,"class":44},"Institute of Hematology & Blood Diseases Hospital, China",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":138,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":45},"100614012","early-phase-1-allogeneic-ucb-derived-car-t-for-sle-100614012","NCT07274059","Allogeneic UCB-derived CAR-T for SLE","Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), regardless of gender.\n* Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE\n* Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.\n* Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.\n* Adequate function of major organs as follows:\n\nBone marrow function: a. Neutrophil count ≥ 1 × 10⁹\u002FL (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g\u002FL.\n\nLiver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).\n\nRenal function: Creatinine clearance rate (CrCl) ≥ 30 mL\u002Fminute (calculated by Cockcroft\u002FGault formula, excluding CrCl reduction caused by SLE).\n\nCoagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.\n\nCardiac function: Hemodynamically stable.\n\n* Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.\n* Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.\n\nExclusion Criteria:\n\n* History of severe drug allergies or atopic diathesis.\n* Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n* Cardiac function insufficient to tolerate the study treatment.\n* Congenital immunoglobulin deficiency.\n* History of malignant tumors within the past 5 years.\n* End-stage renal failure.\n* Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* History of mental illness or severe cognitive impairment.\n* Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.\n* Pregnant females or females planning to become pregnant.\n* Other conditions deemed by the investigator to preclude study participation.",{"count":184,"type":21},48,[24],"The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.",[28],[189,190,191,192],"allogeneic","CAR-T","umbilical cord blood","SLE","2025-12-09",{"date":195,"type":37},"2025-12-10",{"date":197,"type":37},"2025-03-26",{"date":199,"type":21},"2037-12-31",{"name":201,"class":74},"Chengdu Ucello Biotechnology Co., Ltd.",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":138,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":219,"leadSponsor":220,"locationsCount":130},"100613418","early-phase-1-cd19bcma-car-t-for-sle-100613418","NCT07266337","CD19\u002FBCMA CAR-T for SLE","Clinical Study on the Safety and Efficacy of CD19\u002FBCMA CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Aged 18 to 65 years (inclusive), regardless of gender.\n* Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE\n* Treatment refractory: failed ≥ 2 Conventional SLE treatments for at least 3 months.\n* Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.\n* Adequate function of major organs as follows:\n\nBone marrow function: a. Neutrophil count ≥ 1×10⁹\u002FL (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g\u002FL.\n\nLiver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).\n\nRenal function: Creatinine clearance rate (CrCl) ≥ 30 mL\u002Fminute (calculated by Cockcroft\u002FGault formula, excluding CrCl reduction caused by SLE).\n\nCoagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.\n\nCardiac function: Hemodynamically stable.\n\n* Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.\n* Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.\n\nExclusion Criteria:\n\n* History of severe drug allergies or atopic diathesis.\n* Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.\n* Cardiac function insufficient to tolerate the study treatment.\n* Congenital immunoglobulin deficiency.\n* History of malignant tumors within the past 5 years.\n* End-stage renal failure.\n* Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* History of mental illness or severe cognitive impairment.\n* Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.\n* Pregnant females or females planning to become pregnant.\n* Other conditions deemed by the investigator to preclude study participation.",{"count":210,"type":21},24,[24],"The purpose of this clinical trial is to learn if CD19\u002FBCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19\u002FBCMA CAR-T cell product.\n\nThe main questions it aims to answer are:\n\n1. What CAR-T-related adverse events (AEs) occur within 3 months after the CAR-T cell infusion?\n2. Which dose level is the optimal biological dose (OBD)?\n3. What is the the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS?\n\nParticipants will:\n\n1. Receive CD19\u002FBCMA CAR-T cells infusion on Day 0.\n2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.\n3. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after CAR-T cells infusion.",[28],[192,190],"2025-12-03",{"date":217,"type":37},"2025-12-05",{"date":195,"type":21},{"date":199,"type":21},{"name":201,"class":74},{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":242},"100530621","phase-1-mb-cart191-in-refractory-sle-100530621","NCT06189157","MB-CART19.1 in Refractory SLE","An Open-label Phase I\u002FIIa, Multicentre, Interventional Single-arm Trial of MB-CART19.1 in Patients With Refractory SLE","Inclusion Criteria:\n\n1. Patients at least 18 years of age.\n2. Signed and dated informed consent before the conduct of any trial-specific procedure.\n3. SLE fulfilling the 2019 ACR\u002FEULAR classification criteria (refer to Appendix 8).\n4. One BILAG A or two BILAG B despite treatment with at least two of the following treatment options: MMF, cyclophosphamide, rituximab belimumab, anifrolumab, methotrexate, azathioprine.\n5. SLE with major organ involvement defined as either:\n\n   1. Presence of active lupus nephritis according to the following criteria:\n\n      * Histology proven class III or IV lupus nephritis according to ISN\u002FRPS 2003 classification\n      * Urine protein-to-creatinine ratio (UPCR) \\>1 in 24-hour urine collection\n      * Glomerular filtration rate (eGFR) of ≥30 mL\u002Fmin\u002F1.73 m2\n      * No history of kidney transplantation.\n   2. Lupus with heart involvement (e.g., myocarditis, pericarditis, endocarditis) as measured by MRI or echocardiography\u002Fultrasound.\n   3. Lupus with pulmonary involvement (Lupus pleuritis, pulmonary arterial hypertension (PAH)) or lung disease defined as:\n\n      * Forced Vital Capacity (FVC) ≥ 60 % OR\n      * Forced Expiratory Volume (FEV1) ≥ 60 %,Total Lung Capacity (TLC) ≥ 60 %, DLCO (diffusion capacity) ≥ 60 % (according to ATS\u002FERS guidelines).\n6. Absolute CD3+ T cell count ≥ 100\u002Fµl.\n7. No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential. Subjects must agree to use a contraceptive method from screening until 12 months after the administration of the IMP.\n8. Fully vaccinated against SARS-CoV-2 according to the recommendations of RKI or confirmed SARS-CoV-2 infection within the last 6 months.\n\nExclusion Criteria:\n\n1. Active clinically significant central nervous system (CNS) dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis).\n2. Uncontrolled diabetes mellitus.\n3. Therapy induced lung disease and tuberculosis.\n4. Forced Vital Capacity (FVC) \\\u003C 60 %, FEV1 \\\u003C 60 %, Total Lung Capacity (TLC) \\\u003C 60 % and DLCO (diffusion capacity) \\\u003C 60 %.\n5. BILAG A or BILAG B for neuropsychiatric SLE.\n6. History of a malignancy unless disease free for ≥ 5 years with the exception of basal or squamous cell skin cancer.\n7. Cardiac function: Unstable coronary heart disease; left ventricular ejection fraction (LVEF) \\\u003C 50 %; no active myocarditis.\n8. Renal function: eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2.\n9. Liver function: Severe hepatic insufficiency defined as a Child-Pugh score \\> 10(C) (Appendix 10).\n10. Known history of infection with human immunodeficiency virus or active infection with hepatitis B (hepatitis B surface antigen positive).\n11. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative.\n12. Any active, uncontrolled bacterial, viral or fungal infection including SARS-CoV-2.\n13. History of hematopoietic stem cell or solid organ transplantation.\n14. Irreversible organ damage.\n15. Medications:\n\n    * Systemic corticosteroids \\>10 mg within 7 days prior to leukapheresis;\n    * T cell targeting drugs (e.g., mycophenolate mofetil, calcineurin inhibitors) within 21 days prior to leukapheresis;\n    * Prior treatment with anti-CD19 therapy;\n    * Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy;\n    * Live vaccines within 30 days prior to leukapheresis;\n    * Current cytotoxic drugs.\n16. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g., as part of the mandatory preparative chemotherapy or rescue medication\u002Fsalvage therapies for treatment related toxicities.\n17. Contraindication of trial related procedures as judged by the investigator.\n18. Women of childbearing potential (WOCBP) who do not agree to use highly effective contraceptive measures (Pearl index \\\u003C 1) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only acceptable if it is in line with the preferred and usual life style of the participant) or have a vasectomised partner as the sole sexual partner (the vasectomised partner must have received medical assessment of the surgical success) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment.\n\n    A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.\n\n    Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion.\n\n    Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n    A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.\n19. Men with non-pregnant WOCBP partners who do not agree to use highly effective contraceptive measures (Pearl index \\\u003C 1, e.g. spermicide and condom or other highly effective contraceptive measures (Pearl index \\\u003C 1) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment.\n\n    Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.\n20. Concurrent participation in any other interventional trial.\n21. Inability to understand the procedures and risks associated with the trial.",{"count":229,"type":21},29,[142,87],"This is a phase l\u002Fll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels.\n\nIn the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.",[28],"2025-11-20",{"date":235,"type":37},"2025-11-26",{"date":237,"type":37},"2024-08-12",{"date":239,"type":21},"2027-09-30",{"name":241,"class":74},"Miltenyi Biomedicine GmbH",3,{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":114,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":130},"100606619","phase-1-safety-and-efficacy-study-of-cc312-for-moderate-to-severe-sle-100606619","NCT07177911","Safety and Efficacy Study of CC312 for Moderate to Severe SLE","A Phase I Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of CC312 in Patients With Moderate-to-Severe Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.\n* Aged 18 to 65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.\n* Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria.\n* SLEDAI-2000 score ≥7 with at least one BILAG A or two BILAG B domains, despite standard therapy.\n* Meet at least one of the following criteria: positive antinuclear antibody (ANA) ≥1:80 at screening, positive anti-dsDNA antibody at screening, or positive anti-Sm antibody at screening.\n* Have had an inadequate response to at least two standard therapies (e.g., corticosteroids, antimalarials, immunosuppressants, biologics) prior to screening, including at least one immunosuppressant and\u002For biologic. Prior to the first dose, subjects must have been on a stable dose of corticosteroids (e.g., ≤40 mg\u002Fday prednisone or equivalent at screening and during the screening period; if used alone, ≥7.5 mg\u002Fday prednisone or equivalent) and\u002For antimalarials and\u002For immunosuppressants for at least 12 weeks, with doses stable for ≥30 days.\n* Females of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose and refrain from oocyte collection or donation during this period. Their male partners of childbearing potential must also use effective contraception.\n* Males of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation. Their female partners of childbearing potential must also use effective contraception during this period.\n\nExclusion Criteria:\n\n* Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \\>6 g\u002F24 h, or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL, or requiring prohibited medications for active nephritis per protocol, or needing hemodialysis, or receiving prednisone ≥100 mg\u002Fd or equivalent glucocorticoids for ≥14 days).\n* Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, CNS vasculitis) within 8 weeks prior to screening, whether SLE-related or not.\n* History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Other concurrent autoimmune diseases requiring systemic therapy, except for Sjögren's syndrome.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Abnormal laboratory findings at screening:\n\nLiver function: AST\u002FALT or total bilirubin \\>2× upper limit of normal (ULN); Hematology: hemoglobin \\\u003C85 g\u002FL, WBC \\\u003C2.5×10⁹\u002FL, neutrophil count \\\u003C1.0×10⁹\u002FL, platelet count \\\u003C50×10⁹\u002FL; Renal function: eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n\n* Participation in any other clinical trial (including cell or gene therapy) within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).\n* Received CAR-T therapy within 6 months prior to screening.\n* Treatment with B-cell-depleting agents (e.g., rituximab, or therapies targeting CD19\u002FCD20\u002FBAFF) within 6 months prior to screening, unless B-cell levels have returned to pre-treatment or normal ranges.\n* Received non-standard anti-SLE therapies (e.g., Saphnelo) within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening.\n* Received live\u002Fattenuated vaccination within 4 weeks prior to screening or plans to receive such during the trial.\n* Active infection within 14 days prior to screening (bacterial, viral, fungal, parasitic, or other).\n* History of Grade 3-4 allergic reaction (per CTCAE v5.0) to another monoclonal antibody, or known hypersensitivity to any component of CC312 (including recombinant proteins, polysorbate 80, etc.). Patients with transient (≤24 h) Grade ≤3 reactions may be included after discussion with the investigator.\n* Evidence of drug abuse, substance abuse, or alcohol addiction.\n* Major surgery within 4 weeks or minor surgery within 2 weeks prior to screening; wounds must be fully healed (procedures like catheter placement are excluded).\n* History of cardiovascular events within 6 months prior to screening: NYHA Class III\u002FIV heart failure, myocardial infarction, unstable angina, uncontrolled\u002Fsymptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac conditions.\n* Any other severe underlying disease (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, GI bleeding, severe coagulation disorders), psychiatric disorder, or social circumstances that may interfere with trial conduct, compliance, or pose high risk per investigator's judgment.\n* Concurrent malignancy diagnosed within \\\u003C5 years prior to screening.\n* Grade ≥2 bleeding within 30 days prior to screening, or requiring long-term anticoagulants (e.g., warfarin, LMWH, factor Xa inhibitors).\n* Pregnant or lactating women.\n* Positive screening for: tuberculosis (PPD skin test or TB-IGRA, unless with prior adequate anti-TB treatment and no current signs), HIV antibody, HBsAg or HBcAb, HCV antibody, or TP antibody.\n* Any other condition deemed ineligible by the investigator.",{"count":251,"type":21},32,[142],"This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of CC312 in adult patients with moderate to severe systemic lupus erythematosus (SLE).",[28],"2025-09-10",{"date":257,"type":37},"2025-09-17",{"date":259,"type":21},"2025-09-11",{"date":261,"type":21},"2027-09-10",{"name":129,"class":74},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":272,"phases":4,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":130},"100597294","does-belimumab-modify-the-natural-history-of-sle-a-propensity-score-matched-real-world-study-100597294","NCT07056621","Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study","Inclusion Criteria:\n\n* Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria\n* Age ≥ 18 years old\n* Time of follow-up ≥ 6 months\n* Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4\n* Physician Global Assessment (PGA) visual analogue score \\> 1\n\nExclusion Criteria:\n\n* Patients with incomplete medical records or missing key variables\n* Patients with concomitant autoimmune disorders (excluding thyroid disease)",{"count":270,"type":21},684,"1 Year","OBSERVATIONAL","This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece).\n\nThe investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and\u002For inverse probability of treatment weighting, to create balanced cohorts and reduce bias.",[28],[192,276,277],"belimumab","bilag","2025-09-01",{"date":280,"type":37},"2025-09-08",{"date":282,"type":37},"2025-06-30",{"date":284,"type":21},"2026-06",{"name":286,"class":44},"Biomedical Research Foundation, Academy of Athens",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":272,"phases":4,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100605029","associating-gastric-infection-with-autoimmune-flare-severity-in-an-egyptians-100605029","NCT07157202","Associating Gastric Infection With Autoimmune Flare Severity in an Egyptians","Association Between Helicobacter Pylori Infection and Disease Activity in Patients With Systemic Lupus Erythematosus (SLE)","Inclusion Criteria:\n\n* Adult patients (aged ≥18 years) with a confirmed diagnosis of SLE according to the American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n\nPatients who provide written informed consent to participate in the study. Patients who have not received antibiotics or proton pump inhibitors (PPIs) in the four weeks\n\nExclusion Criteria:\n\n* Patients with a history of gastric surgery or known gastrointestinal malignancy.\n\n  * Patients currently receiving immunosuppressive therapy for conditions other than SLE.\n  * Patients with coexisting autoimmune diseases other than SLE.\n  * Pregnant or lactating women.\n  * Patients with active infections (other than H. pylori) at the time of enrollment.",{"count":295,"type":21},115,"A cross-sectional, observational study aims to evaluate the relationship between Helicobacter pylori infection and disease activity in patients diagnosed with systemic lupus erythematosus (SLE), using a combination of structured patient interviews, standardized disease assessments, and laboratory detection of H. pylori by stool antigen testing .",[298,28],"H. Pylori",[192,300],"H. pylori infection","2025-08-28",{"date":303,"type":37},"2025-09-05",{"date":305,"type":21},"2026-08-30",{"date":307,"type":21},"2027-12-30",{"name":309,"class":44},"Assiut University",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":317,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":272,"phases":4,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":4},"100603405","omeract-sle-delphi-100603405","NCT07136090","OMERACT SLE Delphi","OMERACT Systemic Lupus Erythematosus Delphi Survey Via REDCap","Inclusion Criteria:\n\n1. Males and Females\n2. 18 and older\n3. Able to read and understand English, Spanish, French, Italian, Portuguese, Japanese, Arabic, Korean, Hebrew, German, and Chinese\n4. Have access to email and the internet\n\nExclusion Criteria:\n\n1. Not able to read and understand English, Spanish, French, Italian, Portuguese, Japanese, Arabic, Korean, Hebrew, German, and Chinese\n2. Does not have access to email and the internet",true,{"count":319,"type":21},400,"SLE is a chronic multi-systemic autoimmune disease with clinical manifestations characterized by recurrent flares in disease activity and damage in several organs. SLE affects primarily women during child bearing age and is negatively related to productivity, social role participation and health-related quality of life. The multi-systemic nature of SLE and its diverse clinical manifestations have led to many outcome measurements being utilized in SLE clinical trials and longitudinal studies. To standardize measurement in clinical trials and longitudinal studies, the OMERACT SLE Group developed the core domain set for SLE in 1998. A core domain set is a set of outcome measures, capturing all the facets\u002Faspects of the disease, that standardizes measurement and research across clinical trials and longitudinal studies necessary for the advancement of the field. Since development in 1998, many new important domains for SLE have been identified, thus there is an unmet need to update the core domain set. A new OMERACT SLE Working Group has been established to update the SLE core domain set.\n\nThis is a qualitative study that aims to prioritize domains to include in the SLE core domain set. All participants will be asked to complete a four-round online survey. During rounds 1-3 participants will be asked to rate the importance of each domain to be included; round 4 will ask participants select and rank domains. Participants will also have the option of adding other items or descriptors and to provide any other feedback. Each round of the survey will take approximately 15-20 minutes to complete.\n\nParticipants will need to participate in round 1 in order to be invited to round 2, and then participate in round 2 in order to be invited to round 3, and final participate in round 3 in order to be invited to round 4.",[28],[323],"Core Outcome Set","2025-08-19",{"date":326,"type":37},"2025-08-22",{"date":328,"type":21},"2025-09-15",{"date":330,"type":21},"2025-10-31",{"name":332,"class":44},"University Health Network, Toronto",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":340,"targetDuration":271,"studyType":272,"phases":4,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100602971","the-relation-of-albuminglobulin-ratio-and-plateletalbumin-ratio-to-lupus-nephritis-100602971","NCT07130448","The Relation of Albumin\u002FGlobulin Ratio and Platelet\u002FAlbumin Ratio to Lupus Nephritis","The Relation of Albumin\u002FGlobulin Ratio and Platelet\u002FAlbumin Ratio to Lupus Nephritis in Upper Egypt ( Single Center Study)","Inclusion Criteria:\n\n* Patients aged 18 years or older diagnosed as SLE according to 2019 ACR\u002FEULAR classification criteria and with lupus nephritis (LN) according to the ACR criteria.\n* Patients with available baseline laboratory investigations and renal biopsy.\n\nExclusion Criteria:\n\n* Patients with chronic liver disease, hematological disorders, or malignancies affecting albumin\u002Fglobulin ratio or platelet counts.\n* Patients on nephrotoxic medications not related to SLE management.\n* Recent infections or acute inflammatory conditions.",{"count":341,"type":21},120,"Albumin\u002Fglobulin ratio and platelet\u002Falbumin ratio as a predictive non-invasive biomarker for lupus nephritis (LN) presence and severity",[344,28,345],"Lupus Nephritis (LN)","Biomarkers","2025-08-15",{"date":324,"type":37},{"date":349,"type":21},"2025-09",{"date":351,"type":21},"2026-10",{"name":309,"class":44}]