This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in With Relapse/Refractory Autoimmune Diseases.
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
QT-019C will be administered intravenously as per the schedule specified in the protocol.
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
The number and severity of dose-limiting toxicity (DLT) events
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
Time frame: Within 28 Days After QT-019C infusion
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 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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