drugset / Trial / NCT05659628

CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL

NCT05659628

Phase 1 Recruiting 24 enrolled Ningbo No. 1 Hospital Zhejiang University · collab
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2022-12
Primary completion
2024-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19-7×19 CAR-T Cell therapy 2e+06 cells/kg
Subject Tislelizumab Monoclonal antibody 200 mg