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Clinical Trial Summary

This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.


Clinical Trial Description

Systemic lupus erythematosus (SLE) is a kind of autoimmune diseases mediated by autoantibody-forming immune complexes, which involving multiple systems and organs. Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors. Traditional SLE treatment aims at long-term remission, while, CD19- BCMA CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in SLE. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05858684
Study type Interventional
Source RenJi Hospital
Contact Qiong Fu, PhD
Phone 13585603288
Email fuqiong5@163.com
Status Recruiting
Phase Early Phase 1
Start date May 11, 2023
Completion date May 10, 2025

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