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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) by intravenous infusion on Day 0.
Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China
RECRUITINGThe proportion of subjects with DLT
DLT definition is dose-limiting toxicity
Time frame: Within 28 days after GC012F injection infusion
The proportion of subjects with adverse events
All adverse events were evaluated according to NCI-CTCAE v5.0 criteria
Time frame: Within 12 weeks after GC012F injection infusion
Proportion of subjects achieving SRI-4
SELEAN-SLEDAI,BILAG,PGA
Time frame: 4, 8, 12 and 24 weeks after GC012F injection infusion
Number of CAR-T cells and CAR gene copies in subjects'blood and bone marrow (if applicable)
Test method: flow cytometry and qPCR
Time frame: After GC012F injection infusion [day 4, 7, 10, 14 and week 4, 8, 12, 24]
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