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NCT07174843

An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases

StatusRecruiting
PhaseEarly Phase 1
Primary completion (estimated)
Track this trial

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Eligibility criteria expanded, about 50 words
    • Start date changed from estimate of Sep 2025 to Sep 9, 2025
    • Interventions: CD19/CD22/BCMA CAR-T cells(BZE2204) (Biological) to CD19/CD22/BCMA CAR-T cells(BZE2204) (Biological)
    • Secondary endpoints: 12 to 15
    • Study description expanded, about 84 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence and Severity of Adverse Events and Serious Adverse Events
Timeframe: From leukapheresis through Month 6 after infusion
Incidence of Dose-Limiting Toxicities
Timeframe: Day 0 through Day 28

Secondary (15)

Chimeric antigen receptor T cell (CAR-T) levels in peripheral blood at each time point.
Chimeric antigen receptor transgene levels in peripheral blood at each time point
Cytokines levels of IL-2(interleukin), IL-4, IL-6,IL-8, IL-10, IL-12p70, IL-13, IL-1β, TNF-a, IFN-r in peripheral blood at each time point.
B cell levels in peripheral blood at each time point
Changes From Baseline in Serum Immunoglobulin Concentrations
Show 10 moreShow less
The level of muscle enzymes AST(aspartate transaminase), ALT(alanine transaminase), LDH(lactate dehydrogenase), CK(creatine kinase) in peripheral blood at each time point in idiopathic inflammatory myopathies (IIM)
The time of stopping steroids, immunosuppressants for autoimmune disease post infusion
The proportion of subjects with idiopathic inflammatory myopathies(IIM) achieving 2016 total improvement score(TIS) mild, moderate, major improvement; the time to the improvement and the duration of improvement.
The proportion of subjects with immune thrombocytopenia(ITP) achieving complete remission
The proportion of subjects with immune thrombocytopenia(ITP) achieving partial remission
SLE Responder Index-4 (SRI-4) Response Rate in Participants With SLE
Change From Baseline in SLEDAI-2K Score in Participants With SLE
Change From Baseline in Serum Anti-double-stranded DNA Antibody Levels
Change From Baseline in Serum Complement C3 Concentration
Change From Baseline in Serum Complement C4 Concentration

Arms and interventions

BZE2204 CAR-T cell therapyExperimental

Biologicals: CD19/CD22/BCMA CAR-T cells(BZE2204)

Sites

1 site in 1 country

  • Shanghai Mengchao Cancer HospitalShanghai, Shanghai Municipality, China