[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Bioheng Biotech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,96],{"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":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640182","early-phase-1-cd19bcma-targeted-universal-car-t-cell-injection-for-the-treatment-of-autoimmune-diseases-100640182",false,"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.","ALL","18 Years","70 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","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.",[27,28,29,30,31],"SLE - Systemic Lupus Erythematosus","Systemic Sclerosis","ANCA Associated Vasculitis","Idiopathic Inflammatory Myopathies","Sjögren Syndrome",[33],"CD19\u002FBCMA CAR-T","NOT_YET_RECRUITING","2026-05-12",{"date":37,"type":38},"2026-05-19","ACTUAL",{"date":40,"type":21},"2026-04-30",{"date":42,"type":21},"2029-04-30",{"name":44,"class":45},"Nanjing Bioheng Biotech Co., Ltd.","INDUSTRY",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100558245","early-phase-1-clinical-study-on-targeted-cd19-or-cd19-bcma-car-t-therapy-for-autoimmune-diseases-100558245","NCT06548607","Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of CAR-T and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":54,"type":21},20,[24],"This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.",[58,28,29,30,59,60],"SLE (Systemic Lupus)","Sjogren's Syndrome","Autoimmune Diseases","RECRUITING","2026-03-04",{"date":64,"type":38},"2026-03-06",{"date":66,"type":38},"2024-09-14",{"date":68,"type":21},"2027-12-31",{"name":44,"class":45},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":70},"100575717","early-phase-1-clinical-study-on-targeted-cd19bcma-car-t-therapy-for-autoimmune-diseases-100575717","NCT06775912","Clinical Study on Targeted CD19\u002FBCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×109\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×109\u002FL, lymphocyte count \\>0.3×109\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.",{"count":78,"type":21},18,[24],"This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG",[82,28,83,84,85,86,87],"SLE","IIM","NMOSD","MS","MG","ANCA Associated Vasculitis (AAV)","2026-01-30",{"date":90,"type":38},"2026-02-02",{"date":92,"type":38},"2025-01-03",{"date":94,"type":21},"2027-06-01",{"name":44,"class":45},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":70},"100608580","early-phase-1-a-study-of-anti-cd19bcma-universal-car-t-cell-therapy-rd06-05-in-patients-with-autoimmune-diseases-100608580","NCT07203404","A Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","A Clinical Study of the Safety, Efficacy, and Cell Pharmacokinetics of Anti-CD19\u002FBCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Aged ≥18 years and ≤75 years.\n3. Adequate organ function defined as:\n\n   1. Bone marrow function: Defined as absolute neutrophil count (ANC) ≥1500\u002FμL, absolute lymphocyte count (ALC) ≥100\u002FμL, hemoglobin (Hb) ≥80 g\u002FL, and platelet count (PLT) ≥50,000\u002FμL. Transfusions and growth factors must not have been used within 7 days prior to screening to meet these criteria.\n   2. Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN), and total bilirubin \\\u003C1.5 × ULN (or \\\u003C3.0 × ULN for subjects with Gilbert's syndrome).\n   3. Coagulation function: Defined as international normalized ratio (INR) or partial thromboplastin time (PTT) ≤1.5 × ULN.\n   4. Pulmonary function: Defined as dyspnea ≤ Grade 1 per CTCAE and oxygen saturation (SpO₂) ≥92% on room air (by pulse oximetry).\n4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test. Females who are surgically sterile or postmenopausal for at least 2 years are considered not of childbearing potential.\n5. From the time of signing the informed consent form until 6 months after the completion of RD06-05 infusion, female subjects of childbearing potential and male subjects with partners of childbearing potential must use highly effective methods of contraception.\n\nInclusion Criteria for Subjects with Anti-GBM Disease:\n\nDiagnosis of anti-GBM disease according to the 2012 Chapel Hill Consensus Conference definitions, meeting both of the following criteria:\n\n1. Positive for anti-GBM antibody (based on historical or screening test results);\n2. Evidence of renal involvement at screening, defined as:\n\n   1. Presence of active, pathologically confirmed anti-GBM disease (renal biopsy must have been performed within 1 year prior to the screening visit or during the screening period); and\n   2. Accompanied by proteinuria and hematuria.\n\nInclusion Criteria for Subjects with SLE\u002FLN:\n\n1. Diagnosis of SLE according to the 2019 European Alliance of Associations for Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n2. Positive for antinuclear antibody (ANA), and\u002For anti-double-stranded DNA (anti-dsDNA) antibody, and\u002For anti-Smith (anti-Sm) antibody at screening.\n3. SLEDAI-2K score \\> 6 points at screening.\n\nInclusion Criteria for Subjects with AAV\u002FAAGN:\n\n1. Diagnosis of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n2. Positive for anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody at screening or based on historical testing.\n3. For AAV without renal involvement: A Birmingham Vasculitis Activity Score (BVAS) version 3 score of ≥3 at screening, indicating active vasculitis.\n\nInclusion Criteria for Subjects with MN:\n\n1. Diagnosis of primary (idiopathic) membranous nephropathy confirmed by renal biopsy pathology (the renal biopsy must have been performed within 2 years prior to screening or during the screening period).\n2. Meeting the criteria for high-risk or relapsed\u002Frefractory membranous nephropathy:\n\nHigh-risk patients, defined as meeting any of the following criteria:\n\n1. Normal eGFR with urine protein \\>3.5g\u002F24h, a reduction of \\\u003C50% in urine protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C25 g\u002FL or anti-PLA2R antibody \\>50 RU\u002FmL;\n2. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² and\u002For urine protein \\>8g\u002F24h for more than 6 months.\n\nRefractory\u002FRelapsed patients:\n\nRefractory patients are defined as those resistant to prior immunosuppressive therapy (persistent urine protein ≥3.5g\u002F24h with a \\\u003C50% reduction from baseline).\n\nRelapsed patients are defined as those who achieved complete or partial remission with prior immunosuppressive therapy but subsequently developed recurrent urine protein ≥3.5g\u002F24h.\n\nInclusion Criteria for Subjects with SSC:\n\n1. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n2. Diagnosis of diffuse cutaneous SSc at screening.\n\nInclusion Criteria for Subjects with IIM:\n\n1.Diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, corresponding to a probability score of ≥55%). The subtypes include dermatomyositis (DM), anti-synthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).\n\nExclusion Criteria:\n\n1. Subjects with SLE\u002FLN:\n\n   1. Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs\u002Fsymptoms associated with neuropsychiatric lupus, as assessed by a qualified specialist during screening.\n   2. Drug-induced or secondary lupus.\n2. Subjects with AAV\u002FAAGN:\n\n   1. Drug-induced or secondary AAV\u002FAAGN.\n   2. Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.\n3. Subjects with Anti-GBM Disease:\n\n   1. Anuria for more than 7 days.\n   2. Dialysis dependence for more than 30 days.\n   3. Ongoing moderate or severe pulmonary hemorrhage (or cessation within the past two weeks) defined as pulmonary hemorrhage requiring assisted ventilation, supplemental oxygen, or blood transfusion.\n   4. Symptomatic congestive heart failure (NYHA Class 2-4) requiring prescription medication or clinically significant cardiogenic peripheral edema.\n4. Subjects with MN:\n\n   Secondary membranous nephropathy.\n5. Subjects with IIM:\n\n   Presence of severe rhabdomyolysis or CK level ≥120 × ULN at screening.\n6. Subjects with SSc:\n\n   1. History of scleroderma renal crisis within 1 year prior to screening.\n   2. History of cardiac tamponade within 6 months prior to screening.\n   3. Active infection of digital ulcers within 3 months prior to screening.\n   4. Presence of digital gangrene at screening.","75 Years",{"count":105,"type":21},84,[24],"An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19\u002FBCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE\u002FLN, AAV\u002FAAGN, Anti-GBM, MN, SSc, and IIM).",[82,109,29,110,111,112,113,83],"LN","ANCA-Associated Glomerulonephritis","Anti-GBM Disease","MN","SSc","2025-09-23",{"date":116,"type":38},"2025-10-02",{"date":118,"type":38},"2025-07-24",{"date":120,"type":21},"2028-07-23",{"name":44,"class":45},""]