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Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease

StatusRecruiting
PhaseEarly Phase 1
Started2025-01-30
View on ClinicalTrials.gov ↗

Amendment history

2025-11-24
minor
Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility v3
Enrollment target72→36
Eligibility criteria-67 characters
[...] ac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML/min/1.73m2; (For patients with a [...] irolimus, leflunomide, telitacicept, Beliumab, and rituximab,etc,al); or Intolerant to standard treatments; or the dosage of st [...] -hour urine protein quantification ≥500mg or UPCR≥0.5mg/mg; ≥ >50% decline in eGFR within 3 months; Patients who are unable [...] medical condition that would prevent the administration of anti-CD19 CAR NK Cells (KN5501)KN5601, except for lupus (determined by the investigator) Received [...]
Secondary endpointsdetails revised at 1 of 1 entry
2025-09-01
minor
Study Identification, Study Status, Oversight, Study Description, Conditions, Outcome Measures, Eligibility v2
Eligibility criteria+832 characters
[...] hropathy(MCD) or focal segmental glomerulosclerosis (FSGS); IgA nephropathy Age: ≥ 5 years old, male or female; IgA nephropathy pathologically confirmed by renal biopsy; 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: Combination or sequent [...] Exclusion Criteria: Subjects with known severe allergic reac [...]
Secondary endpointsdetails revised at 1 of 1 entry
Study description+326 characters
[...] e, there is a pressing need for new therapeutic strategies. Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. Although immunosuppressants have been used in some patients, IgAN remains a leading cause of kidney failure in young adults, with approximately 40% of patients progressing to end-stage kidney disease (ESKD) [...] Since 2019, CAR T-cell therapy has shown success in treating [...] volutionizing the treatment of refractory SLE and MDR-SRNS, IgAN, offering new hope for patients with these challenging conditions.
2025-02-09
notable
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2025-01-23
minor
Original filing
this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.
Trial Details
NCT Number NCT06792799
Lead Sponsor The Children's Hospital of Zhejiang University School of Medicine
Conditions Autoimmune Diseases, Systemic Lupus Erthematosus, Multi-Drug Resistant Nephrotic Syndrome, IgAN - IgA Nephropathy
Enrollment 36 participants
Start Date 2025-01-30
Primary Completion 2028-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-01