RecruitingEarly Phase 1NCT07174843

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


Sponsor

Shanghai Cell Therapy Group Co.,Ltd

Enrollment

20 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CD19/CD22/BCMA CAR-T cells(BZE2204) for people with idiopathic inflammatory myopathies(iim), immune thrombocytopenia (itp), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19/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

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NCT07174843


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