NCT07174843

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

An Exploratory Clinical Study to Evaluate the Safety and Efficacy of BZE2204 CD19/CD22/BCMA CAR-T Cells in Subjects With Relapsed or Refractory Active Autoimmune Diseases

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in patients with relapsed or refractory active autoimmune diseases, including idiopathic inflammatory myopathies(IIM), immune thrombocytopenia(ITP), systemic lupus erythematosus(SLE).

Detailed description

This is a single arm, open-label, dose escalation and expansion exploratory study, the primary objective is to evaluate the safety and tolerability of BZE2204 in patients with active relapsed or refractory autoimmune diseases, and determine the maximum tolerated dose (MTD) or recommended dose(RD) for future study. For the secondary objectives, pharmacokinetics(PK), pharmacodynamics (PD) and preliminary will be evaluated. This study flow comprises of a screening phase( ≤28 days prior to apheresis), apheresis phase (occur upon enrollment, ≤10 days prior to infusion), baseline phase(2-3days before the infusion), BZE2204 CAR-T cells infusion on Day0,safety and efficacy assessments phase (Day1 to Month6), long-term follow-up phase (Month6\~Month12).

Conditions

• Idiopathic Inflammatory Myopathies(IIM)
• Immune Thrombocytopenia(ITP)
• Systemic Lupus Erythematosus(SLE)

Interventions

Type	Name	Description
BIOLOGICAL	CD19/CD22/BCMA CAR-T cells(BZE2204)	Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of BZE2204 CAR T cells. On day0 subjects will receive a single dose BZE2204 CAR T cells by intravenous (IV) injection.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

1 site across 1 country: China