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Recruiting Phase 2 NCT06794008

BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases

Trial Parameters

Condition Systemic Lupus Erythematosus
Sponsor Peking University People's Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-12-26
Completion 2027-12-30
Interventions
BCMA-CD19 CAR-T therapy

Brief Summary

The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.

Eligibility Criteria

Inclusion Criteria: 1. Age, 18-65 years old (inclusive), weight \>=45kg, male and female; 2. The diagnosis of each disease meets the following criteria: Systemic lupus erythematosus: 1997 ACR classification criteria or 2012 SLICC classification criteria Sjögren's syndrome: 2002 International Classification of Sjögren's Syndrome Inflammatory myopathies: 1977 Bohan Recommendation Systemic sclerosis: 1980 ACR classification criteria or 2013 ACR-EULAR classification criteria Behcet's disease: 1989 International Classification Criteria for Behcet's disease ANCA-associated vasculitis: 1990 ACR classification criteria IgG4-related disease: 2011 IgG4-RD composite diagnostic criteria Antiphospholipid syndrome: 2006 revision of the Sapporo APS classification criteria Acquired thrombotic thrombocytopenic purpura: consistent with a clinical diagnosis of TTP, including microscopic evidence of thrombocytopenia and red blood cell fragmentation (e.g., red blood cell fragmentation) 3. Multiple treatmen

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