This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.
Systemic lupus erythematous (SLE) is a chronic diffuse connective tissue disease with unexplained etiology that can involve multiple systems in the body. SLE is considered as an incurable disease and traditional SLE treatment aims at long-term remission. Glucocorticoids combined with immunosuppressive agents are still the main treatment strategies. Recently, biological agents targeting abnormal immune cells, such as rituximab and belimumab, which deplete B cells have also achieved some success in the treatment of SLE. However, these agents cannot permanently reverse the production of abnormal antibodies as they are unable to eliminate pathogenic long-lived plasma cells. The BCMA-CD19 CAR T-cells are designed to deplete antibody-producing 'root", B cells and plasma cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
BCMA-CD19 cCAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
Zhongshan People's Hospital
Zhongshan, Guangdong, China
RECRUITINGThe number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion
Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after CAR infusion.
Time frame: 3 months after CAR infusion
Autoantibody detection
Autoantibody detection up to 6 months after BCMA-CD19 cCAR T cells infusion
Time frame: 6 months after CAR infusion
SLEAI score
SLEAI score taken up to 2 years after BCMA-CD19 cCAR T cells infusion
Time frame: 2 years after CAR infusion
Renal functions
Renal functions monitored up to 1years after BCMA-CD19 cCAR T cells infusion
Time frame: 1 year after CAR infusion
Disease control
Disease control monitored up to 2 years after BCMA-CD19 cCAR T cells infusion)
Time frame: 2 years after CAR infusion
Overall survival
Overall survival (2 year after CAR infusion). The time from the start of BCMA-CD19 cCAR infusion to death is determined as the overall survival
Time frame: 2 years after CAR infusion
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