This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide will be administered intravenously.
Fludarabine will be administered intravenously.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
The incidence and severity of adverse events (AEs)
Time frame: 2 years
To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases
Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
Time frame: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
AUC0-28d
Time frame: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Cmax
Time frame: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Tmax
Time frame: 2 years
To characterize pharmacodynamics of of UCAR-T cells in participants.
Changes in B-cell levels in the peripheral blood from baseline.
Time frame: 2 years
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