This study aims to evaluate the safety and tolerance of modified CD19 CAR T cells in treating refractory/relapsed B-cell malignancies. CAR-T cells will be investigated as a single agent both in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) and up to 60% of patients with B-cell non-Hodgkin's lymphoma (NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
intravenous infusion
Sichuan University
Chengdu, Sichuan, China
RECRUITINGIncidence of treatment-emergent adverse events [Safety and Tolerability]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Up to 5 years after modified CD19 CAR-T cells infusion
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after modified CD19 CAR-T cells infusion
B-cell malignancies, Overall response rate(ORR)
Assessment of ORR(ORR=CR+PR)
Time frame: 3 months, 6 months
B-cell malignancies, Overall survival
From the first infusion of modified CD19 CAR-T cells to death or the last visit
Time frame: Up to 2 years after modified CD19 CAR-T cells infusion
B-cell malignancies, progression-free survival(PFS)
From the first infusion of modified CD19 CAR-T cells to the occurrence of any event, including death, relapse, disease progression, and the last visit
Time frame: Up to 2 years after modified CD19 CAR-T cells infusion
B-cell malignancies, disease control rate (DCR)
Assessment of DCR(DCR=CR+PR+SD)
Time frame: Month 6,12,18 and 24
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