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RECRUITING
NCT07174843
EARLY_PHASE1

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

Sponsor: Shanghai Cell Therapy Group Co.,Ltd

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-09

Completion Date

2027-12

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China