[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multi-drug-resistant-nephrotic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multi-drug-resistant-nephrotic-syndrome":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,76,97,118,139],{"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":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684","NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","3 Years",{"count":55,"type":21},15,[24],"This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[27,59,32,60,61,62],"Systemic Lupus Erthematosus (SLE)","IgA Nephropathy (IgAN)","Systemic Sclerosis (SSc)","ANCA Associated Systemic Vasculitis",[64,32,59,60,61,65],"UCART","ANCA associated systemic vasculitis","RECRUITING","2026-05-12",{"date":69,"type":37},"2026-05-14",{"date":71,"type":21},"2026-05-08",{"date":73,"type":21},"2030-12-31",{"name":43,"class":44},1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":51,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":75},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":55,"type":21},[24],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[27,59,32,60,61,62],[64,32,87,31,61,88],"Systemic Lupus Erthematosus","ANCA-Associated Vasculitis (AAV)","2026-03-30",{"date":91,"type":37},"2026-04-02",{"date":93,"type":21},"2026-04-01",{"date":95,"type":21},"2029-12",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":75},"100616400","phase-1-car-t-cell-therapy-targeting-cd19-and-bcma-in-patients-with-b-cell-mediated-autoimmune-disease-100616400","NCT07305116","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease","Inclusion Criteria:\n\n\\- Common Inclusion Criteria:\n\n1\\. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%. 2. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n\n3\\. Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n\nDisease-Specific Inclusion Criteria\n\nSLE:\n\n1. Age ≥ 5 years.\n2. Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) Treated with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, thalidomide, belimumab, or rituximab) for at least 3 months.\n\n   b) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   c) Patients who cannot taper glucocorticoids to ≤5 mg\u002Fday after 6 months of conventional therapy.\n4. SLE disease activity: SLEDAI-2K score ≥ 8; or SLEDAI ≥ 6 plus at least one BILAG-2004 category A or two category B scores, or both.\n5. No occurrence of macrophage activation syndrome within 1 month prior to screening.\n6. Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n\nMDR-SRNS\n\n1. Age ≥3 years old, gender unlimited.\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n3. Must meet at least one of the following adequate treatment conditions:\n\n   a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n\n   b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n\n   c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n\n   d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n4. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n   a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg; b) \\>50% decline in eGFR within 3 months; c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Scleroderma fulfilling the 2013 ACR classification criteria\n3. Positive scleroderma-related antibodies.\n4. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n5. Must meet at least one of the following adequate treatment conditions:\n\n   1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n   2. Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n   3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n6. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. Age: ≥ 5 years old, gender unlimited;\n2. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n3. Has received glucocorticoids (≥1 mg\u002Fkg\u002Fday) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, telitacicept, etc.) for at least 3 months without achieving sustained remission, or has experienced relapse after remission;or meets the criteria for severe vasculitis (Appendix 1), with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n4. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n5. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n\n  2\\. Subjects with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n\n  4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n\n  5\\. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n\n  7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n\n  8\\. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or congenital immunodeficiency. 11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n\n  12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n\n  13\\. Received live vaccine within 4 weeks before screening. 14. Tested positive in Blood pregnancy test. 15. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n\n  16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n\n  17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome",{"count":55,"type":21},[106],"PHASE1","CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.",[27,59,32,60,61,62],[110,32,87,31,61,88],"CAR-T","2026-01-31",{"date":113,"type":37},"2026-02-03",{"date":115,"type":37},"2025-12-01",{"date":95,"type":21},{"name":43,"class":44},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":75},"100577015","early-phase-1-anti-cd19bcma-car-nk-cells-in-patients-with-b-cell-mediated-autoimmune-disease-100577015","NCT06792799","Anti-CD19\u002FBCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease","An Exploratory Clinical Study on the Safety and Efficacy of CD19\u002FBCMA Chimeric Antigen Receptor NK Cells in the Treatment of B Cell-related Autoimmune Diseases in Children","Inclusion Criteria:\n\n1. Patients or their legal guardians must acknowledge the risks and procedures involved and subsequently provide informed consent to participate in the clinical trial.\n2. Predicted survival time ≥ 12 weeks;\n3. ECOG: 0\\~2;\n4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% ;\n5. Renal function: eGFR≥30ML\u002Fmin\u002F1.73m2； (For patients with an eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² or those receiving renal replacement therapy, inclusion or exclusion in the study is determined at the discretion of the investigators. )\n6. Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN;\n7. Lung function: No serious lung lesions, SpO2≥92%;\n8. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-NK infusion;\n\nSLE:\n\n1. Age:≥5 years old;\n2. Diagnosed with SLE according to the 2019 EULAR\u002FACR SLE classification criteria；\n3. Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg\u002Fkg\u002Fd or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab,etc,al); or Intolerant to standard treatments; or the dosage of steroid can not be reduced to 5mg\u002Fd after 6-month of routine treatment.\n4. SLEDAI 2K score\\>6 points;\n5. No history of Central nervous system (CNS) disease within 60 days prior to screening;\n6. No history of macrophage activation syndrome (MAS) within one month prior to screening.\n\nMDR-SRNS\n\n1. Age ≥3 years old, gender unlimited;\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes （KDIGO） Guidelines and have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission (at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus; Other hormone replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab); Or if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin inhibitor, if the researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks and the patient or guardian has fully informed consent;\n3. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old, male or female;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n   1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n   2. \\>50% decline in eGFR within 3 months;\n   3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nExclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, obinutuzumab), or subjects with a history of severe allergic reactions\n2. Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；\n3. Subjects with grade III or IV heart failure (NYHA classification)\n4. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs；\n5. Renal replacement therapy has been or is being performed within 3 months prior to transfusion;\n6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive;\n7. Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening;\n8. Patients had seizure, or other active central nervous system disease;\n9. Patients with malignant diseases such as tumors before screening, or with other serious life-threatening diseases;\n10. Secondary or congenital immunodeficiency.\n11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of KN5601, except for lupus (determined by the investigator)\n12. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus-host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening;\n13. Received live vaccine within 4 weeks before screening;\n14. Subjects who have received B cell-targeted drug therapy within 1 month before enrollment\n15. Tested positive in Blood pregnancy test；\n16. Patients who participated in other clinical study within 3 months prior to enrollment;\n17. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria\n18. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome",{"count":126,"type":21},36,[24],"this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19\u002FBCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.",[27,87,32,31],[131,32,87,31],"car-nk","2025-11-24",{"date":115,"type":37},{"date":135,"type":37},"2025-01-30",{"date":137,"type":21},"2029-06-30",{"name":43,"class":44},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":75},"100558651","phase-1-study-of-therapeutic-efficacy-of-car-t-cell-therapy-in-patients-with-mdr-srns-100558651","NCT06553898","Study of Therapeutic Efficacy of CAR-T Cell Therapy in Patients With MDR-SRNS","Study of Therapeutic Efficacy of Anti-B Cell Maturation Antigen（BCMA）\u002FCluster of Differentiation 70(CD70 )CAR-T Cells in Patients With Multi-drug Resistant SRNS","Inclusion Criteria:\n\n* 1\\. Age ≥2 years old, gender unlimited;\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes （KDIGO） Guidelines and have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission (at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus; Other hormone replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab); Or if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin inhibitor, if the researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks and the patient or guardian has fully informed consent;\n* 3\\. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* 4\\. The functions of important organs are basically normal: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML\u002Fmin\u002F1.73m2# Liver function: Asparagus cochinchinensis transaseminase (AST) and Alanine Aminotransferase (ALT)≤3.0 upper limit of normal, Total Bilirubin (TBIL) in serum ≤2.0×upper limit of normal; Lung function: No serious lung lesions, SpO2≥92%;\n* 5\\. Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;\n* 6\\. Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-T infusion;\n* 7\\. Participants or their guardians agrees to participate in the clinical trial and sign the informed consent form which indicating that he\u002Fshe understands the purpose and procedure of the clinical trial and is willing to participate in the study.\n\nExclusion Criteria:\n\n* 1\\. Received CAR T cell therapy or other gene-modified cell therapy previously;\n* 2\\. Patients had a cerebrovascular accident or seizure, or other active central nervous system disease within 6 months;\n* 3\\. Genetic tests have confirmed hereditary kidney disease;\n* 4\\. Renal biopsy has been confirmed as immunoglobulin A nephropathy, idiopathic membranous nephropathy or membranoproliferative glomerulonephritis;\n* 5\\. Renal replacement therapy has been or is being performed within 3 months prior to transfusion. (if acute kidney injury factors were considered, patients with chronic kidney disease were excluded, and the benefits outweighed the risks as determined by the investigator and with the full and informed consent of the patient or guardian could be considered for inclusion);\n* 6\\. Renal replacement therapy has been or is being performed within 3 months prior to transfusion;\n* 7\\. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs;\n* 8\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus-host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening;\n* 9\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive;\n* 10\\. Macrophage activation syndrome occurred within 1 month prior to screening;\n* 11\\. Received live vaccine within 4 weeks before screening;\n* 12\\. Patients with malignant diseases such as tumors before screening, or with other serious life-threatening diseases;\n* 13\\. Tested positive in Blood pregnancy test;\n* 14\\. Patients who participated in other clinical study within 1 months prior to enrollment;\n* 15\\. Any other conditions that the investigators deem it unsuitable for the study.","2 Years",{"count":148,"type":21},18,[106],"This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA\u002FCD70 CAR-T cells in the treatment of patients with Multi-drug resistant SRNS",[32,152],"CAR-T Cell Therapy",[154,155,32],"MDR-SRNS","CAR-T cell therapy","2025-08-28",{"date":158,"type":37},"2025-08-29",{"date":160,"type":37},"2024-08-13",{"date":162,"type":21},"2027-07-31",{"name":43,"class":44}]