Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were accumulated, including rare and delayed complications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Up to 28 years after Treatment
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 2 years after Treatment
Overall response rate ,ORR
The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
Time frame: Up to 12 weeks after CAR-T infusion
Duration of remission ,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Time frame: Up to 1 years after CAR-T infusion
Event-free survival, EFS
The time from first achieving CR/CRi to relapse or death
Time frame: Up to 1 years after CAR-T infusion
Overall survival, OS
The time from CAR-T infusion to death due to any cause
Time frame: Up to 1 years after CAR-T infusion
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