[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-autoimmune-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-autoimmune-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,69,93,114],{"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":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100642246","early-clinical-study-on-the-safety-tolerability-pharmacokinetics-and-efficacy-of-str-p005-100642246",false,"NCT07655453","Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005","Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005 in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n1. Voluntarily participate in this study and sign the informed consent form.\n2. Aged 18 to 75 years (inclusive).\n3. Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry.\n4. Adequate organ function:\n\n   1. Hematology: Absolute Neutrophil Count (ANC) ≥1.0×10\\^9\\^\u002FL, Absolute Lymphocyte Count (ALC) ≥0.1×10\\^9\\^\u002FL, Hemoglobin ≥80 g\u002FL, Platelet count (PLT) ≥50×10\\^9\\^\u002FL. Blood transfusion and growth factors cannot be used within 7 days prior to eligibility screening to meet these requirements.\n   2. Coagulation: International Normalized Ratio (INR) ≤1.5 × Upper Limit of Normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.\n   3. Liver function: Serum AST, ALT ≤3.0 × ULN, Total Bilirubin ≤1.5 × ULN (for subjects with Gilbert's syndrome, Total Bilirubin \\\u003C3.0 × ULN).\n   4. Renal function: Serum creatinine ≤1.5 × ULN or Creatinine Clearance (CrCl) ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula); if with renal involvement, CrCl ≥45 mL\u002Fmin.\n   5. Cardiac function: New York Heart Association (NYHA) Class I or II, and Left Ventricular Ejection Fraction (LVEF) ≥50% by Echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or Ischemic Heart Disease (IHD) within 8 weeks prior to screening.\n   6. Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.\n\n      \\-\n\nExclusion Criteria:\n\n1. Patients who have received any cell immunotherapy in the past, except where there is evidence that the engineered immune cells have disappeared and peripheral blood B cells are still present.\n2. Unable to meet the following washout periods for therapeutic drugs:\n\n   1. Use of therapeutic doses of corticosteroids (Prednisone ≥20mg\u002Fday or equivalent dose of other corticosteroids) within 72 hours prior to first dose, but topical or inhaled steroids are allowed.\n   2. Use of mycophenolate mofetil or its derivatives, azathioprine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), JAK inhibitors (e.g., tofacitinib, ruxolitinib, upadacitinib) within at least 2 weeks prior to screening.\n   3. Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks prior to screening.\n   4. Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month prior to screening; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52 mAb, anti-CD38 mAb, ATG within at least 3 months.\n   5. Other monoclonal antibodies, bispecific antibodies, trispecific antibodies, antibody-drug conjugates (ADC), or any B-cell depleting drugs require a washout of 3 months or 5 half-lives (whichever is shorter) prior to screening.\n   6. Undergone plasmapheresis, plasma separation, hemodialysis, intravenous immunoglobulin (IVIG) within 2 weeks prior to screening.\n3. History of ≥ Grade 2 bleeding within 30 days prior to screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, or Factor Xa inhibitors), except if INR ≤ 1.5 × ULN.\n4. Severe renal disease: Severe lupus nephritis within 8 weeks prior to screening \\[defined as urine protein \\> 6g\u002F24 hours or serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL or creatinine clearance (Cockcroft-Gault formula) \\\u003C 30 mL\u002Fmin\\], or active nephritis requiring treatment with prohibited medications, or requiring prednisone \\>100mg\u002Fday or equivalent corticosteroid for ≥14 days.\n5. Severe pulmonary disease within 3 months prior to screening, such as moderate-to-severe pulmonary hypertension (mean pulmonary artery pressure \\> 60 mmHg by echocardiography), requiring oxygen therapy via reservoir mask or non-invasive\u002Finvasive mechanical ventilation at screening.\n6. Occurrence of lupus crisis within 3 months prior to screening, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.\n7. History or related symptoms of active non-lupus-induced central nervous system disease (excluding isolated trigeminal nerve disease) within 6 months prior to screening, including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, and symptoms such as epilepsy, convulsions, aphasia, dementia, etc.\n8. Occurrence of any of the following cardiovascular diseases within 6 months prior to screening (including but not limited to):\n\n   1. Congestive heart failure, myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary\u002Fperipheral artery bypass surgery.\n   2. Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes); congenital long QT syndrome, left anterior hemiblock (bifascicular block), complete left bundle branch block or high-grade AV block; history of severe non-ischemic cardiomyopathy; asymptomatic right bundle branch block is allowed for study entry.\n   3. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.\n   4. Current active cardiac involvement, such as pericarditis, pericardial effusion, and myocarditis.\n9. Active tuberculosis or latent tuberculosis at screening (defined as positive tuberculin skin test or interferon-gamma release assay without clinical symptoms or radiographic evidence).\n10. Screening results showing HBV-DNA, HCV-RNA, CMV-DNA above the laboratory's detection limit, or HIV antibody positive.\n11. Presence of uncontrolled fungal, bacterial, viral or other infections deemed unsuitable for study participation by the investigator.\n12. Presence of uncontrolled diabetes mellitus (HbA1c ≥ 7.0%); and uncontrolled thyroid disease (TSH \\> 10 mIU\u002FL or \\\u003C 0.1 mIU\u002FL, and FT4 outside normal range).\n13. History of major organ transplant (e.g., heart, lung, kidney, liver) or history of allogeneic hematopoietic stem cell transplant within 12 weeks or autologous hematopoietic stem cell transplant within 6 weeks prior to screening.\n14. Congenital immunoglobulin deficiency.\n15. Thrombotic Thrombocytopenic Purpura (TTP)\u002FThrombotic Microangiopathy (TMA).\n16. Concomitant history of other autoimmune diseases (including but not limited to eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behçet's disease, or Takayasu's arteritis) requiring systemic treatment, besides the target indications.\n17. Family history of non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy.\n18. History or concurrent presence of other active malignancies, including patients with malignancy-associated polymyositis\u002Fdermatomyositis. Exceptions: carcinoma in situ of the cervix, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, ductal carcinoma in situ of the breast post-resection, and papillary thyroid cancer that have been cured and without recurrence for at least 2 years.\n19. History of hypersensitivity or life-threatening reaction to the study drug or any of its components or formulation ingredients.\n20. Pregnant or breastfeeding women.\n21. Received any live attenuated vaccine within 6 weeks prior to first dose, or planned to receive one within 3 months after treatment.\n22. Participation in another interventional clinical study and received an active investigational drug within 3 months prior to signing ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.\n23. Patients with mental illness such as depression or suicidal tendencies.\n24. Other factors considered by the investigator to make the subject unsuitable for enrollment or affect the subject's participation or completion of the study.\n\n    \\-","ALL","18 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in subjects with relapsed\u002Frefractory autoimmune diseases.\n\nThe study will employ the traditional \"3+3\" dose escalation model, setting up 3 dose groups: Amg\u002Fkg, Bmg\u002Fkg, C mg\u002Fkg. Dose Group 1 will serve as the starting dose, with two cohorts A and B within this group aimed at optimizing the dosing frequency of STR-P005. Cohort A will receive dosing every 3 days (Q3D), on D1, D4, D7 (3 doses) constituting one cycle, which can be repeated for 2 cycles. Cohort B will receive dosing every 4 days (Q4D), on D1, D4 (2 doses) constituting one cycle, which can be repeated for 2 cycles. Based on the preliminary safety data, efficacy information, and PK\u002FPD parameters obtained from Cohorts 1A and 1B, the investigators will select the superior regimen and escalate sequentially to Dose Groups 2 and 3. If no MTD is found after dose escalation through the 3 groups, based on all available preliminary safety data, efficacy information, and PK\u002FPD parameters, higher doses may be added for further exploration of safety and efficacy after discussion by the SRC.",[27],"Relapsed\u002FRefractory Autoimmune Diseases","NOT_YET_RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-17","ACTUAL",{"date":34,"type":21},"2026-08-01",{"date":36,"type":21},"2028-07-30",{"name":38,"class":39},"Starna Therapeutics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100638495","early-clinical-study-of-the-safety-tolerability-pharmacokinetics-and-effectiveness-of-str-p005-100638495","NCT07605637","Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005","Early Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Effectiveness of STR-P005 for the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1\\. Voluntarily participate and sign informed consent. 2. Age 18 to 75 years (inclusive). 3. Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry.\n\n  4\\. Adequate organ function:\n  1. Hematology: Absolute neutrophil count (ANC) ≥1.0×10\\^9\\^\u002FL, absolute lymphocyte count (ALC) ≥0.1×10\\^9\\^\u002FL, hemoglobin ≥80 g\u002FL, platelet count (PLT) ≥50×10\\^9\\^\u002FL. Transfusion and growth factors cannot be used within 7 days prior to screening to meet these requirements.\n  2. Coagulation: International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n  3. Liver function: Serum AST, ALT ≤3.0 × ULN, total bilirubin ≤1.5 × ULN (for participants with Gilbert's syndrome, total bilirubin \\\u003C3.0 × ULN).\n  4. Renal function: Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥60 mL\u002Fmin (Cockcroft Gault formula); if renal involvement, CrCl ≥45 mL\u002Fmin. \\|\n  5. Cardiac function: New York Heart Association (NYHA) class I or II, left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or ischemic heart disease (IHD) within 8 weeks prior to screening.\n  6. Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.\n\n     Exclusion Criteria:\n* Participants meeting \\*\\*ANY\\*\\* of the following exclusion criteria cannot be enrolled:\n\n  1. Previous treatment with any cellular immunotherapy, unless there is evidence that engineered immune cells have disappeared and B cells are still present in peripheral blood.\n  2. Failure to meet the following treatment washout periods:\n\n     1. Use of therapeutic doses of corticosteroids (prednisone ≥20 mg\u002Fday or equivalent) within 72 hours before first dose, though topical or inhaled steroids are allowed.\n     2. Use of mycophenolate mofetil or its derivatives, azathioprine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), JAK inhibitors (e.g., tofacitinib, ruxolitinib, upadacitinib) within at least 2 weeks before screening.\n     3. Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks before screening.\n     4. Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month or more; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52, anti-CD38, ATG within at least 3 months before screening.\n     5. Other monoclonal, bispecific, trispecific antibodies, ADCs, or any B-cell depleting drugs must be washed out for 3 months or 5 half-lives (whichever is shorter) before screening.\n     6. Undergone plasmapheresis, plasma separation, hemodialysis, IVIG within 2 weeks before screening.\n  3. History of ≥ Grade 2 bleeding within 30 days before screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors), unless INR ≤1.5 × ULN.\n  4. Severe renal disease: Severe lupus nephritis within 8 weeks before screening \\[defined as urine protein \\>6g\u002F24h or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL or CrCl (Cockcroft Gault) \\\u003C30 mL\u002Fmin\\], or active nephritis requiring treatment with prohibited medications, or requiring prednisone \\>100 mg\u002Fday or equivalent corticosteroid therapy for ≥14 days.\n  5. Severe pulmonary disease within 3 months before screening, such as moderate-to-severe pulmonary arterial hypertension (mean pulmonary artery pressure \\>60 mmHg by ECHO), requiring oxygen therapy via mask or non-invasive\u002Finvasive mechanical ventilation at screening.\n  6. History of lupus crisis within 3 months before screening, such as active CNS lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.\n  7. History or symptoms of active non-lupus-related CNS disease within 6 months before screening (excluding isolated trigeminal nerve disease), including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, etc., as well as symptoms like epilepsy, convulsions, aphasia, dementia.\n  8. Occurrence of any of the following cardiovascular diseases within 6 months before screening (including but not limited to):\n\n     1. Congestive heart failure, myocardial infarction, unstable angina, coronary angioplasty, stent implantation, coronary\u002Fperipheral artery bypass grafting.\n     2. Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes); congenital long QT syndrome, left anterior hemiblock (bifascicular block), complete left bundle branch block or high-grade AV block; history of severe non-ischemic cardiomyopathy. Asymptomatic right bundle branch block is allowed.\n     3. Uncontrolled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.\n     4. Current evidence of active cardiac involvement, such as pericarditis, pericardial effusion, myocarditis.\n  9. Active tuberculosis or latent tuberculosis at screening (defined as positive tuberculin skin test or interferon-gamma release assay, without clinical symptoms or radiological evidence).\n  10. Positive for HIV antibodies, or HBV-DNA, HCV-RNA, CMV-DNA exceeding assay upper limit of normal at screening.\n  11. Presence of uncontrolled fungal, bacterial, viral, or other infections deemed unsuitable for study participation by the investigator.\n  12. Presence of uncontrolled diabetes (HbA1c ≥7.0%); uncontrolled thyroid disease (TSH \\>10 mIU\u002FL or \\\u003C0.1 mIU\u002FL, and FT4 outside normal range).\n  13. History of major organ transplant (e.g., heart, lung, kidney, liver) or allogeneic hematopoietic stem cell transplant within 12 weeks or autologous stem cell transplant within 6 weeks prior to screening.\n  14. Congenital immunoglobulin deficiency.\n  15. Thrombotic thrombocytopenic purpura (TTP)\u002Fthrombotic microangiopathy (TMA).\n  16. History of other autoimmune diseases (including but not limited to eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, inclusion body myositis, anti-GBM disease, Behçet's disease, or Takayasu's arteritis) requiring systemic treatment, besides the target indication.\n  17. Family history of non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy.\n  18. Previous or concurrent other active malignancies, including patients with cancer-associated polymyositis\u002Fdermatomyositis. Exceptions: cured cervical carcinoma in situ with no recurrence for at least 2 years, non-invasive basal cell or squamous cell skin cancer, radically treated localized prostate cancer, ductal carcinoma in situ of the breast post-mastectomy, and papillary thyroid cancer.\n  19. History of hypersensitivity or life-threatening reaction to the study drug or any of its components or formulation ingredients.\n  20. Pregnant or breastfeeding women.\n  21. Vaccination with any live attenuated vaccine within 6 weeks before first dose, or planned vaccination within 3 months after treatment.\n  22. Participation in other interventional clinical studies, received active investigational drug within 3 months before signing ICF, or intention to participate in another clinical trial or receive autoimmune disease treatment outside the protocol during the entire study.\n  23. Psychiatric patients with depression or suicidal tendencies.\n  24. Other factors deemed by the investigator to make the participant unsuitable for enrollment or unable to complete the study.",{"count":48,"type":21},18,[24],"This is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in participants with relapsed\u002Frefractory autoimmune diseases.\n\nThe study will employ a traditional \"3+3\" dose-escalation design, with 3 dose groups: XXmg\u002Fkg, XXmg\u002Fkg, XXmg\u002Fkg. Dose Group 1 is the starting dose. This group includes two cohorts, A and B, to optimize the dosing frequency of STR-P005. Cohort A will receive doses Q3D (once every 3 days) on Days 1, 4, 7 (3 doses per cycle), for up to 2 cycles. Cohort B will receive doses Q4D (once every 4 days) on Days 1, 4 (2 doses per cycle), for up to 2 cycles. Based on preliminary safety, efficacy, PK\u002FPD data from Cohorts 1A and 1B, the superior regimen will be selected for escalation to Dose Groups 2 and 3. If no optimal dose is identified after escalating through the 3 dose groups, additional higher doses may be explored after SRC discussion based on all accumulated preliminary safety, efficacy, and PK\u002FPD data to further evaluate the safety and efficacy of STR-P005.",[27],[53,54,55,56,57,58],"SLE","dcSSc","ANCA","AAV","IIM","SS","2026-05-18",{"date":61,"type":32},"2026-05-26",{"date":63,"type":21},"2026-06-01",{"date":65,"type":21},"2027-11-30",{"name":67,"class":68},"Beijing GoBroad Hospital","OTHER",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100627412","early-phase-1-a-clinical-study-of-afn50-in-the-treatment-of-autoimmune-diseases-100627412","NCT07448298","A Clinical Study of AFN50 in the Treatment of Autoimmune Diseases","Inclusion Criteria:\n\n1\\. General Inclusion Criteria 1.1 Must be capable of understanding and voluntarily providing written informed consent.\n\n1.2 Age 18 to 69 years (inclusive), any gender. 1.3 Adequate bone marrow, coagulation, cardiac, pulmonary, hepatic, and renal function at screening:\n\nBone Marrow Function:\n\n* Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL (no use of granulocyte colony-stimulating factor (G-CSF) within 7 days before screening; for long-acting G-CSF, a 14-day interval is required); ② Haemoglobin (Hb) ≥90 g\u002FL (no red blood cell transfusion within 14 days before screening; use of recombinant human erythropoietin is permitted); ③ Platelet count (PLT) ≥75 × 10⁹\u002FL; absolute lymphocyte count (ALC) ≥0.5 × 10⁹\u002FL.\n\nCoagulation Function: International normalised ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5 × the upper limit of normal (ULN).\n\nCardiac Function: Left ventricular ejection fraction (LVEF) ≥50% as shown by echocardiography (ECHO).\n\nPulmonary Function: Dyspnea ≤ CTCAE Grade 1, and pulse oxygen saturation (SpO₂) \\>92% on room air.\n\nHepatic Function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 × ULN; total bilirubin ≤1.5 × ULN.\n\nRenal Function: Creatinine clearance (Cockcroft-Gault formula) ≥50 mL\u002Fmin, without requiring fluid support.\n\n1.4 Baseline oxygen saturation \\>92% without supplemental oxygen. 1.5 Non-pregnant\u002Fnon-lactating subjects. Women of childbearing potential must have a negative serum or urine pregnancy test report (women who have undergone surgical sterilisation or are postmenopausal for at least 2 years are not considered to be of childbearing potential) and must be willing to use contraception for 12 months following drug infusion.\n\nDisease-Specific Inclusion Criteria：\n\n1. Relapsed\u002FRefractory Systemic Lupus Erythematosus (SLE) 1.1 Meet the 2019 European Alliance of Associations for Rheumatology\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE.\n\n   1.2 SLEDAI-2K score ≥6; if the score includes low complement and\u002For anti-dsDNA antibodies, the SLEDAI-2K clinical symptom score after excluding these two items must be ≥4.\n\n   1.3 History of SLE for at least 6 months, with disease remaining active or relapsing despite receiving stable standard therapy for at least 8 weeks (drug doses stable for the past 2 weeks).\n\n   1.4 Oral glucocorticoids (prednisone or equivalent) at a daily dose ≥7.5 mg and ≤30 mg; if combined with immunosuppressants, there is no minimum daily dose requirement.\n\n   1.5 At least two immunosuppressants (including hydroxychloroquine) have been used in a standardised manner.\n\n   1.6 Screening tests meet: positive serum antinuclear antibody (ANA), and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For hypocomplementemia (low C3 and\u002For low C4).\n\n   1.7 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Stable use, alone or in combination, of the following drugs: non-steroidal anti-inflammatory drugs (NSAIDs), antimalarials, glucocorticoids, immunosuppressants (including but not limited to cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine), targeted drugs (including but not limited to belimumab, telitacicept, eculizumab, rituximab).\n2. Relapsed\u002FRefractory Sjögren's Syndrome (SS) 2.1Meet the 2002 AECG criteria or the 2016 ACR\u002FEULAR classification criteria for primary Sjögren's Syndrome.\n\n   2.2 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n3. Refractory Myasthenia Gravis (MG) 3.1 Meet the diagnostic criteria for generalized myasthenia gravis as per the Chinese guidelines for the diagnosis and treatment of MG (2025 edition).\n\n   3.2 Myasthenia Gravis Foundation of America (MGFA) clinical classification: Type II, III, or IV.\n\n   3.3 Positive serology for acetylcholine receptor antibody (AChR-Ab), or muscle-specific tyrosine kinase antibody (MuSK-Ab), or low-density lipoprotein receptor-related protein 4 antibody (LRP4-Ab) at screening, or documented history of positive AChR-Ab, MuSK-Ab, or LRP4-Ab.\n\n   3.4 Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥6, with ocular-related scores comprising less than 50% of the total score.\n\n   3.5 Myasthenia Gravis (QMG) score ≥8, with at least 4 individual item scores being ≥2 points.\n\n   3.6 Definition of refractory: Ineffective to conventional therapy or disease reactivation following remission.\n4. Relapsed\u002FRefractory or Progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) 4.1 Meet the 2013 ACR classification criteria for systemic sclerosis, with diffuse cutaneous involvement.\n\n   4.2 Presence of interstitial lung disease: evidence of interstitial changes with ground-glass opacity on chest HRCT and forced vital capacity (FVC) or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C70% of predicted value on pulmonary function tests.\n\n   4.3 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or disease reactivation following remission.\n\n   4.4 Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n\n   4.5 Definition of progressive disease:\n   1. Skin progression: Increase in modified Rodnan skin score (mRSS) \\>10%.\n   2. Lung disease progression: Decrease in FVC by 10%, or decrease in FVC by 5% accompanied by a decrease in DLCO by 15% (OMERACT progression).\n5. Relapsed\u002FRefractory or Progressive Idiopathic Inflammatory Myopathy (IIM) 5.1 Meet the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including DM, PM, ASS, and NM).\n\n   5.2 For patients with muscle involvement: Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician Global Activity (PhGA), Patient Global Activity (PtGA) or extra-muscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels 1.5 times the upper limit of normal).\n\n   5.3 Positive myositis antibodies. 5.4 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n\n   5.5 Definition of progressive disease: Rapidly progressive interstitial pneumonia occurring within a short period.\n6. Relapsed\u002FRefractory Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV) 6.1 Meet the 2022 ACR\u002FEULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n\n6.2 Positive ANCA-related antibodies (MPO-ANCA or PR3-ANCA). 6.3 Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total 63 points), indicating active vasculitis.\n\n6.4 The BVAS assessment must include at least one major item, at least three minor items, or at least two renal items (hematuria and proteinuria).\n\n6.5 Definition of relapsed\u002Frefractory: Ineffective to conventional therapy or recurrence of disease activity after remission. Definition of conventional therapy: Use of glucocorticoids (≥1 mg\u002Fkg\u002Fday) and cyclophosphamide, plus any one or more of the following immunomodulatory drugs for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, telitacicept, etc.\n\nExclusion Criteria:\n\n1\\. General Exclusion Criteria 1.1 Individuals with positive hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA or titer above the detection threshold; positive hepatitis C virus (HCV) antibody with detectable HCV RNA or titer above the detection threshold; positive human immunodeficiency virus (HIV) antibody; detectable cytomegalovirus (CMV) DNA or level above the detection limit; positive syphilis antigen or antibody.\n\n1.2 Presence of other uncontrolled active infections. 1.3 History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow\u002Fhematopoietic stem cell transplantation.\n\n1.4 Received any mRNA-LNP product or other LNP-based therapy within the past 2 years and has a history of allergy to LNPs or their components.\n\n1.5 Received live vaccination within the past 30 days. 1.6 History of any severe cardiovascular disease within 6 months prior to screening, including: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac disease.\n\n1.7 Pregnant or lactating women. 1.8 Individuals with asthma or a history of severe allergies. 1.9 According to the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up or compliance with study participation requirements.\n\n1.10 Other unspecified reasons that, in the opinion of the investigator, render the patient unsuitable for enrollment.\n\nDisease-Specific Exclusion Criteria\n\n1. Relapsed\u002FRefractory Systemic Lupus Erythematosus: Concurrent neuropsychiatric lupus; thrombotic thrombocytopenic purpura (TTP)\u002Fmicroangiopathy (TMA).\n2. Relapsed\u002FRefractory Sjögren's Syndrome: Concurrent liver cirrhosis; concurrent aplastic anaemia (AA), myelodysplastic syndrome (MDS), or other myeloproliferative disorders (MPD); drug-induced thrombocytopenia; TTP\u002FTMA.\n3. Relapsed\u002FRefractory Myasthenia Gravis: Presence of an uncontrolled myasthenic crisis within 2 weeks prior to screening.\n4. Relapsed\u002FRefractory or Progressive Diffuse Cutaneous Systemic Sclerosis: NYHA Class IV cardiac function; presence of moderate to severe pulmonary hypertension (mean pulmonary artery pressure \\>40 mmHg by echocardiography); FVC \\\u003C45% of predicted value; DLCO \\\u003C40% of predicted value; significant abnormalities on HRCT not attributable to SSc; persistent unexplained hematuria (\\>5 red blood cells per high-power field) or creatinine clearance \\\u003C40 mL\u002Fmin; prior history of autologous stem cell transplantation; signs of renal crisis; active gastric antral vascular ectasia.\n5. Relapsed\u002FRefractory or Progressive Idiopathic Inflammatory Myopathy: Drug-induced myositis; inclusion body myositis; cancer-associated myositis (myositis occurring within 2 years of cancer diagnosis).\n6. Relapsed\u002FRefractory ANCA-Associated Vasculitis:\n\nEstimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m²; if the participant has alveolar haemorrhage requiring invasive mechanical ventilation expected to last beyond the screening period; requiring dialysis or plasma exchange during the screening period; or prior kidney transplantation.","69 Years",{"count":48,"type":21},[78],"EARLY_PHASE1","This study is a single-arm, open-label, single-centre exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of AFN50 Injection in adult patients with B-cell-mediated refractory\u002Freplapased autoimmune diseases.",[27],[82],"Autoimmune Diseases","RECRUITING","2026-03-09",{"date":86,"type":32},"2026-03-11",{"date":84,"type":32},{"date":89,"type":21},"2029-02-28",{"name":91,"class":68},"Beijing Boren Hospital",1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":5},"100600252","early-phase-1-a-study-of-lucar-dks1-in-subjects-with-relapsedrefractory-autoimmune-diseases-100600252","NCT07095075","A Study of LUCAR-DKS1 in Subjects With Relapsed\u002FRefractory Autoimmune Diseases","An Open-label Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed\u002FRefractory Autoimmune Diseases (r\u002Fr AID)","* Inclusion Criteria:\n\n  1. Subjects voluntary agreement to provide written informed consent.\n  2. Aged 18 to 70 years, either sex.\n  3. Clinical laboratory values meet screening criteria.\n  4. Positive test for CD19 and\u002F or BCMA\n\nSLE:\n\n* Meets at least 1 classification criteria≥6 months for SLE.\n* At screening, antinuclear antibody, and\u002For anti-dsDNA antibody, and\u002For anti-Smith antibody should be positive.\n* Fulfill relapsed\u002Frefractory SLE conditions.\n\nAAV:\n\n* Meets the 2022 ACR\u002FEULAR classification criteria for AAV.\n* Positive test for anti-MPO or p-ANCA or anti-PR3 or anti-MPO antibodies at screening.\n* Fulfill relapsed\u002Frefractory AAV conditions.\n\nSSc:\n\n* Meets the 2013 ACR\u002FEULAR classification criteria for SSc.\n* At screening, mRSS is higher than 10.\n* Fulfill relapsed\u002Frefractory SSc conditions.\n\nIIM:\n\n* Meets 2017 EULAR\u002FACR classification criteria for IIM.\n* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.\n* Fulfill relapsed\u002Frefractory IIM conditions. SjS：\n* Meets the 2016 ACR\u002FEULAR diagnostic criteria for SjS.\n* Positive test for anti-SSA and\u002For anti-SSB antibodies at screening.\n* Fulfill relapsed\u002Frefractory SjS conditions.\n\nExclusion Criteria:\n\n1. Active infections such as hepatitis and tuberculosis.\n2. Other autoimmune diseases.\n3. Serious underlying diseases such as tumor, uncontrolled diabetes.\n4. Female subjects who were pregnant, breastfeeding.\n5. Those with a history of major organ transplantation.\n6. Have received autologous cell therapy of any target before.","70 Years",{"count":20,"type":21},[78],"This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed\u002Frefractory autoimmune diseases.",[27],"2025-12-09",{"date":107,"type":32},"2025-12-10",{"date":109,"type":32},"2025-10-14",{"date":111,"type":21},"2029-12-31",{"name":113,"class":39},"Nanjing Legend Biotech Co.",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":92},"100607831","car-t-in-subjects-with-relapsedrefractory-autoimmune-disease-100607831","NCT07193667","CAR-T in Subjects With Relapsed\u002FRefractory Autoimmune Disease","CAR-T Cell Therapy in Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* age 18-65 years (including threshold) and gender;\n* positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;\n* the function of vital organs meets the following requirements:\n\n  1. Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109\u002FL; b. Neutrophil count ≥1×109\u002FL (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g\u002FL;\n  2. Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).\n\n     TBIL≤1.5×ULN (except Gilbert's syndrome, total bilirubin≤3.0×ULN);\n  3. Renal function: creatinine clearance (CrCl) ≥ 30 ml\u002Fminute (Cockcroft\u002FGault formula, except for disease-induced decline in CrCl);\n  4. Coagulation: international normalized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) ≤ 1.5 x ULN.\n  5. Cardiac function: hemodynamic stability;\n* female subjects of childbearing potential and male subjects with a partner of childbearing potential are required to use medically approved contraception or be abstinent from sexual intercourse for at least 6 months during and after study treatment; female subjects of childbearing potential must have had a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding;\n* Voluntarily participate in this clinical study and sign the informed consent form, good compliance and cooperate with follow-up visits.\n* Specific inclusion criteria:\n* Relapsed refractory systemic lupus erythematosus.\n* meets the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE;\n* have a Disease Activity Score SLEDAI⁃2000 ≥ 6; and have at least one British Isles Lupus Assessment Group Index (BILAG-2004) Category A (severe manifestations) or two Category B (moderate manifestations) organ scores, or both; or have a Disease Activity Score SLEDAI-2000 ≥ 8;\n* Definition of relapse-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.\n* Relapsing Refractory\u002FProgressive Diffuse Systemic Sclerosis\n* meets the 2013 ACR's classification criteria for systemic sclerosis consistent with a diffuse presentation\n* is positive for antibodies related to systemic sclerosis;\n* diffuse cutaneous sclerosis manifestations or active interstitial lung disease (HRCT suggestive of ground-glass exudates);\n* definition of relapsing-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.\n* Definition of Progressive: Rapid cutaneous progression (\\>25% increase in mRSS); or pulmonary progression (10% decrease in FVC, or \\>5% decrease in FVC with 15% decrease in DLCO).\n* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.\n* Relapsed refractory\u002Fprogressive inflammatory myopathy\n* meets the 2017 EULAR\u002FACR classification criteria for inflammatory myopathies (including DM , PM, ASS, and NM);\n* is positive for antibodies to myositis;\n* in those with muscle involvement, an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measurements (PhGA, PtGA, or Extramuscular Disease Activity Score ≥2; Total HAQ Score ≥0.25); Myosin level 1.5 times the upper limit of the normal range); or MMT-8 ≥142 in the presence of active interstitial lung disease (HRCT suggestive of ground-glass exudates);\n* Definition of relapse refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.\n* Definition of progressive: the presence of exacerbation of myositis or rapidly progressive interstitial pneumonia.\n* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.\n* Relapsed Refractory\u002FProgressive Immune Thrombocytopenia\n* meets the 2019 American Society of Hematology (ASH) classification criteria for immune thrombocytopenia;\n* have bone marrow morphology characterized by increased or normal megakaryocytes with impaired maturation;\n* exclude other secondary thrombocytopenia\n* Definition of recurrent refractory: a patient who fails to achieve a satisfactory outcome after first-line standard therapy (e.g., glucocorticoids), including a full dose and course of therapy, i.e., platelet counts that cannot be maintained at a safe level (generally considered to be platelet counts \\> 30 × 10⁹ \u002FL and without overt bleeding symptoms).\n* Definition of progressive: a sustained decline in platelet count over the course of the disease, or a progressive worsening of bleeding symptoms, which may be accompanied by signs such as splenomegaly, and a progressively worse response to conventional therapy.\n* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.\n\nExclusion Criteria:\n\n* A history of severe drug allergies or sensitivities;\n* the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment\n* persons with central nervous system disorders caused by ADs or not caused by ADs.\n* those with intolerable cardiac function;\n* subjects with congenital immunoglobulin defects.\n* history of malignant tumors within the last five years.\n* end-stage renal failure;\n* subjects with positive Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of the test; subjects with positive antibody to Hepatitis C virus (HCV) and peripheral blood HCV RNA; subjects with positive antibody to Human Immunodeficiency Virus (HIV); and subjects with a positive test for Syphilis;\n* mental illness and severe cognitive impairment;\n* have participated in other clinical trials within 3 months prior to enrollment;\n* immunosuppressants or biologics with a therapeutic effect for the indication within five half-lives prior to enrollment\n* women who are pregnant or intend to become pregnant;\n* subjects who, in the opinion of the investigator, have other reasons for not being included in the study.","65 Years",{"count":123,"type":21},3,[24],"In this study, CD19 CAR-T cells were administered to patients with relapsed\u002Frefractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed\u002Frefractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.",[27],[128],"CAR-T","2025-09-24",{"date":131,"type":32},"2025-09-26",{"date":133,"type":21},"2025-10",{"date":135,"type":21},"2027-12",{"name":137,"class":39},"ShenZhen Cell Valley"]