Phase Ib Clinical Study of CD19 CAR-T Expressing IL-7 and CCL19 Combined With Tislelizumab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

• DLBCL refractory or relapse is defined as: complete remission is not achieved after 2-line treatment; let What disease progress occurs during treatment, or the disease stability time is equal to or less than 6 months; Or autologous hematopoietic stem Disease progression or recurrence within 12 months after cell transplantation;

• Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody) and anthracyclines;

• At least one measurable lesion is required, and any lymph node lesion with a length greater than 1.5cm or extranodal lesion is required If any length diameter is greater than 1.0 cm, the lesions on PET-CT scan have uptake (SUV is larger than liver blood pool);

• Absolute value of peripheral blood neutrophils ≥ 1000/ μ l. Platelets ≥ 45000/ μ l

• Heart, liver and kidney functions: creatinine \< 1.5mg/dL; ALT/AST Less than 2.5 times of normal upper limit; Total bilirubin \< 1.5mg/dL; Cardiac ejection fraction (EF) ≥ 50%;

⁃ Have sufficient understanding and voluntarily sign the informed consent form;

⁃ People with fertility must be willing to use contraceptive methods;

⁃ According to the judgment of the researcher, the expected survival period is at least 4 months;

⁃ Willing to follow the visit schedule, administration plan, laboratory inspection and other test steps.

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital
RECRUITING
Hangzhou
Ningbo First Hospital
RECRUITING
Ningbo
Contact Information
Primary
Lixia Sheng, doctor
slx800408@163.com
86-574-87085596
Time Frame
Start Date: 2022-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 24
Treatments
Experimental: CAR-T combined with anti-PD1 treatment group
CD19-7×19 CAR-T combined with Tislelizumab
Sponsors
Leads: Ningbo No. 1 Hospital
Collaborators: Zhejiang University

This content was sourced from clinicaltrials.gov

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