The goal of this clinical trial is to test CD19-7×19 CAR-T cells combined with Tislelizumab in refractory and relapsed diffuse large B lymphoma. The main question\[s\] it aims to answer are: question 1:What is the safety of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma. question 2:What is the efficacy of CD19-7×19 CAR-T cells combined with Tislelizumab in the treatment of relapsed or refractory diffuse large B-cell lymphoma. Participants will be asked to receive clinical evaluation before CAR-T, including physical examination, blood routine test, biochemical test, imaging test, etc.Peripheral blood lymphocytes will be collected for preparation of CAR-T cells after enrollment. Pretreatment chemotherapy with fludarabine and cyclophosphamide will be used before CAR-T infusion. On the 31st day after CAR-T infusion, Tislelizumab 200mg was given once every 21 days for 6 cycles. Participants will be required to report concomitant medication and adverse events, and their disease was evaluated throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive 2×106/Kg CD19-7×19 CAR-T cells infusion and Tislelizumab 200mg every 21 days for 6 cycle on the 31st day after CAR-T infusion.
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
Hangzhou, Zhejiang, China
RECRUITINGNingbo First Hospital
Ningbo, Zhejiang, China
RECRUITINGAdverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.
Time frame: Measured from start of treatment until 28 days after last dose.
Objective Response Rate
Proportion of CR and PR subjects will be assessed at 3 months post-infusion.
Time frame: up to 3 months
Progress free survival time
To measure the duration of response over a follow-up period of 24 months.
Time frame: up to 24 months
Overall survival
OS will be assessed from the first chimeric antigen receptor T cells (CAR-T) given to death or last follow-up.
Time frame: up to 24 months
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