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

ConditionDiffuse Large B-cell Lymphoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Combination product

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: CAR-T combined with anti-PD1 treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse 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.
2

Objective Response Rate

Proportion of CR and PR subjects will be assessed at 3 months post-infusion.

Time frame
up to 3 months

Secondary outcomes

1

Progress free survival time

To measure the duration of response over a follow-up period of 24 months.

Time frame
up to 24 months
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ningbo No. 1 Hospital

Lead sponsor

Zhejiang University

Collaborator

Source ClinicalTrials.gov
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