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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNingbo No. 1 Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18, upper limit 75, male or female;

ECOG score 0-3;

Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [diagnostic criteria according to WHO 2008];

CD19 positive (immunohistochemistry or flow cytometry).

Disqualifiers

Have a history of other tumors;

Autologous hematopoietic stem cell transplantation was performed within 6 weeks;

Any target CAR-T treatment was performed within 3 months before this CAR-T treatment;

Previously used any commercially available PD-1 monoclonal antibody;

Trial design

Treatments tested in this trial

  • CD19-7×19 CAR-T combined with Tislelizumab

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ningbo No. 1 Hospital

Lead sponsor

Zhejiang University

Collaborator