An Early Phase 1 interventional study of Assigned Interventions CD19/BCMA CAR T-cells in Scleroderma and Autoimmune Diseases, sponsored by Zhejiang University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by Zhejiang University · Early Phase 1, Interventional, and Treatment
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells. This fully reflects the application prospects of CAR-T cells in autoimmune diseases.
Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory scleroderma
Exclusion Criteria:
Subjects with any of the following exclusion criteria were not eligible for this trial:
Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4\*10E6/kg are administrated for each subject.
Biological: Assigned Interventions CD19/BCMA CAR T-cells
Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after CD19/BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 90 days after CD19/BCMA CAR T-cells infusion
Concentration of CAR-T cells
In peripheral blood
Time frame: From admission to the end of the follow-up, up to 2 years
Objective Response Rate, ORR
Proportion of subjects with complete or partial remission
Time frame: In 3 months of CD19/BCMA CAR-T cell infusion
Disease control rate, DCR
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
Time frame: From Day 28 CD19/BCMA CAR-T infusion up to 2 years
Duration of remission, DOR
The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause
Time frame: 24 months post CD19/BCMA CAR-T cells infusion
Progression-free survival, PFS
The time from cell reinfusion to the first assessment of disease progression or death from any cause
Time frame: 24 months post CD19/BCMA CAR-Tcells infusion
Overall survival, OS
The time from the cell reinfusion to death due to any cause
Time frame: From CD19/BCMA CAR-T infusion to death，up to 2 years
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Zhejiang University