[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iim--idiopathic-inflammatory-myopathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iim--idiopathic-inflammatory-myopathies":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"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.","18 Years","65 Years",{"count":56,"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":63,"type":37},"2026-04-14",{"date":65,"type":37},"2025-09-23",{"date":67,"type":21},"2027-09-29",{"name":69,"class":70},"CytoCares Inc","INDUSTRY",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":76,"conditions":83,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":71},"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":80,"type":21},12,[82],"PHASE1",[28,29,30,84,85,86],"ANCA Associated Vasculitis (AAV)","Connective Tissue Disease-Associated Thrombocytopenia","SLE-ITP","2026-01-15",{"date":89,"type":37},"2026-01-20",{"date":91,"type":21},"2026-01-01",{"date":93,"type":21},"2029-01-18",{"name":95,"class":44},"Institute of Hematology & Blood Diseases Hospital, China"]