[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"igan---iga-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:igan---iga-nephropathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100649182","phase-2-phase-ii-clinical-study-on-the-efficacy-and-safety-of-qls7305-in-patients-with-kidney-disease-part-a-100649182",false,"NCT07730632","Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)","A Phase II Clinical Study Evaluating the Efficacy and Safety of QLS7305 in Patients With Primary IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Primary Membranous Nephropathy (PMN)","Inclusion Criteria:\n\n* Body weight ≥ 40 kg, Body Mass Index (BMI) \\\u003C 32.5 kg\u002Fm²\n* Within the five years prior to screening, patients must have been diagnosed with primary IgAN or PMN through renal biopsy, or within one year prior to screening, diagnosed with C3G or IC-MPGN through renal biopsy, accompanied by glomerular C3 deposition; if a renal biopsy has not been previously performed, a renal biopsy must be conducted during the screening period to confirm eligibility criteria.\n* Participants with IgAN and C3G\u002FIC-MPGN: During the screening period, morning urine UPCR or 24-hour UPCR ≥0.75 g\u002Fg or 24-hour UP ≥1 g\u002Fday, with the average of two 24-hour UPCR measurements at baseline ≥0.75 g\u002Fg; PMN participants: During the screening period, morning urine or 24-hour UP ≥3.5 g\u002Fday, with the average of two 24-hour UP measurements at baseline ≥3.5 g\u002Fday.\n* During the screening and baseline periods, eGFR ≥ 30 ml·min-¹·1.73 m-² (using the CKD-EPI formula)\n* Prior to the first administration, the patient should have received the maximum tolerated dose or the maximum dose recommended in the instructions of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) for at least 12 weeks, and the dose of the ACEi or ARB should have been stable for at least 4 weeks before the first administration.\n* Voluntarily receive meningococcal and pneumococcal vaccines at least 2 weeks before the first administration of the investigational drug in accordance with the protocol requirements.\n* From the time of signing the informed consent form until 12 months after the last administration of the investigational drug, there are no plans for sperm or egg donation, no plans for pregnancy, and voluntary use of effective contraceptive measures.\n\nExclusion Criteria:\n\n* Renal biopsy pathology indicates tubular atrophy or interstitial fibrosis exceeding 50%.\n* Renal biopsy pathology indicates crescent formation in more than 50% of glomeruli, or clinical presentation suggests the possibility of rapidly progressive glomerulonephritis (RPGN) (eGFR decline ≥50% within 3 months).\n* Participants were evaluated by the investigator as having IgAN, C3G, IC-MPGN, or PMN secondary to conditions such as infection, autoimmune diseases, or monoclonal immunoglobulin-associated diseases.\n* Participants were evaluated by the investigator as having other systemic diseases or other kidney diseases that could lead to proteinuria, such as diabetic nephropathy, IgA vasculitis, lupus nephritis, or ANCA-associated small vessel vasculitis.\n* Participants were determined to have acute kidney injury (AKI) within 30 days prior to screening and before administration of the study drug.\n* Participants were on dialysis at the time of screening or might require dialysis treatment during the study.\n* Participants had received B cell-targeting biologics, such as rituximab or ocrelizumab, within 180 days prior to the first administration of the study drug.\n* Participants had used other biologics, such as infliximab or eculizumab, within 90 days prior to the first administration of the study drug.\n* Participants who received sodium-glucose co-transporter 2 inhibitors (SGLT2i) within 90 days prior to the first administration of the study drug are excluded, except for those who had been on stable SGLT2i therapy for 90 days or more prior to the first administration and continued stable use during the study.\n* Participants who received mineralocorticoid receptor antagonists (MRA), such as spironolactone, eplerenone, or finerenone, within 30 days prior to the first administration of the study drug are excluded, except for those who had been on stable MRA therapy for 90 days or more prior to the first administration and continued stable use during the study.\n* Participants with a history of kidney transplantation, organ transplantation, or hematopoietic stem cell transplantation are excluded.\n* Participants with any history of malignancy within 5 years prior to screening are excluded, except for those who have been cured (such as basal cell carcinoma, cutaneous squamous cell carcinoma, low-risk\u002Fvery low-risk localized prostate cancer, papillary thyroid carcinoma, etc.) or have undergone radical resection of carcinoma in situ (such as ductal carcinoma in situ of the breast, cervical carcinoma in situ, etc.).\n* History of active tuberculosis within 1 year prior to screening, or deemed by the investigator to have active tuberculosis at screening.\n* Participants with chronic recurrent infections within 1 year prior to screening, such as liver abscess, chronic pyelonephritis, etc.\n* Surgery requiring general anesthesia or hospitalization for more than 1 day within 30 days prior to screening or planned during the trial.\n* Administration of live attenuated vaccines other than those allowed in the protocol within 30 days prior to screening or planned during the study.\n* Clinically significant infection requiring systemic anti-infective treatment within 30 days prior to the first administration of the investigational product.\n* History of recurrent invasive infections with encapsulated bacteria (e.g., Neisseria meningitidis and Streptococcus pneumoniae).\n* History of severe drug allergy, or allergic reaction to oligonucleotides or N-acetylgalactosamine (GalNAc).\n* Poorly controlled type 1 or type 2 diabetes, defined as baseline glycated hemoglobin (HbA1c) ≥7.0%.\n* Poorly controlled hypertension, defined as baseline seated resting systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg.\n* History of renal artery stenosis, chronic hyperkalemia, or other contraindications to RAS inhibitors (RASi).","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","QLS7305 injection is a chemically synthesized double-stranded small interfering RNA (siRNA) targeting complement C3, covalently linked to a ligand containing N-acetylgalactosamine (GalNAc) residues. After subcutaneous (SC) administration, it can inhibit C3 synthesis through the RNA interference (RNAi) mechanism, reduce circulating C3 protein levels, decrease the generation of complement-activated C5 convertase, and inhibit complement pathway activation. It is expected to become an effective treatment for complement-mediated kidney diseases and hematological disorders.",[26,27,28,29],"IgAN - IgA Nephropathy","Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)","C3 Glomerulopathy (C3G)","Primary Membranous Nephropathy",[31,32,33,34],"IC⁃MPGN","C3G","PMN","IgAN","NOT_YET_RECRUITING","2026-07-22",{"date":38,"type":39},"2026-07-28","ACTUAL",{"date":41,"type":20},"2026-08-10",{"date":43,"type":20},"2028-08-11",{"name":45,"class":46},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100644814","early-phase-1-rd06-05-universal-cd19bcma-car-t-for-refractory-pediatric-autoimmune-diseases-100644814","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.","5 Years","20 Years",{"count":58,"type":20},30,[60],"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).",[63,64,65,66,26,67],"Autoimmune Diseases","SLE - Systemic Lupus Erythematosus","SSc-Systemic Sclerosis","IIM- Idiopathic Inflammatory Myopathies","Multi-Drug Resistant Nephrotic Syndrome","2026-06-23",{"date":70,"type":39},"2026-06-29",{"date":72,"type":20},"2026-07",{"date":74,"type":20},"2030-07",{"name":76,"class":77},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":47},"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","3 Years",{"count":88,"type":20},36,[60],"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.",[63,92,67,26],"Systemic Lupus Erthematosus",[94,67,92,26],"car-nk","RECRUITING","2025-11-24",{"date":98,"type":39},"2025-12-01",{"date":100,"type":39},"2025-01-30",{"date":102,"type":20},"2029-06-30",{"name":76,"class":77}]