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

Recruiting Early Phase 1 Interventional Study
Idiopathic Inflammatory Myopathies(IIM) Immune Thrombocytopenia(ITP) Systemic Lupus Erythematosus(SLE)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Shanghai Cell Therapy Group Co.,Ltd · Industry
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About This Trial
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(…
Trial Locations
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Eligibility Criteria
Major Inclusion Criteria: 1. Males or females, aged 18-70 years old 2. Adequate bone marrow, hepatic, renal, coagulation and pulmonary function defined as: * Bone marrow reservation: absolute neutrophil count (ANC) ≥1 ×10\^9/L; absolute lymphocyte count (ALC)≥ 0.5 ×10\^9/L; hemoglobulin ≥80 g/L…
Contacts

Jinxing Lou

021-67091399

loujx@shcell.com

CONTACT