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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T combined with anti-PD1 treatment group | Experimental | CD19-7×19 CAR-T combined with Tislelizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival time | To measure the duration of response over a follow-up period of 24 months. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lixia Sheng, doctor | Contact | 86-574-87085596 | slx800408@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University, Ningbo First Hospital | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| up to 24 months |
| Ningbo First Hospital | Recruiting | Ningbo | Zhejiang | 315010 | China |
|
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |