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This study aims to evaluate the efficacy and safety of Relma-cel in the treatment of central nervous system lymphoma (CNSL), as well as its pharmacokinetic characteristics. Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by Tislelizumab treatment (200mg, IV, q4w, for 12 months) starting on day 35 after infusion. Bruton's tyrosine kinase (BTK) inhibitors will be used in combination as needed. The follow-up period will last for 4 years, monitoring drug safety, disease status, survival, and the pharmacokinetic characteristics of Relma-cel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | Relma-cel Followed by Tislelizumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relma-cel Followed by Tislelizumab | Drug | Enrolled patients with relapsed/refractory (R/R) CNSL will receive Relma-cel infusion, followed by treatment with Tislelizumab (200mg, IV, q4w, for 12 months) starting at 35 days post-infusion. BTK inhibitors will be used in combination as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) at 3-month | Complete response rate at 3-month is defined as the incidence of subjects achieving complete response (CR) at 3-month after CAR-T infusion according to the Lugano Classification, as determined by study investigators. | 3 months post CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause. | 2 years post CAR-T infusion |
| Overall Survival (OS) |
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Inclusion Criteria:
Age greater than or equal to 18 years old, male or female;
Relapsed or refractory CNS-involved large b-cell lymphoma after at least first-line therapy, with an efficacy assessment of CR or PR after salvage therapy, and current stable efficacy status;
Eastern Cooperative Oncology Group (ECOG) score of 0-2;
Have a life expectancy of ≥ 12 weeks
Use contraception
Have adequate bone marrow and organ function:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenyan Yu | Contact | +86 13564230293 | 1152227516@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beljing Tiantan Hospital, Capttal Medical, University | Not yet recruiting | Beijing | China |
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OS is defined as the time from CAR-T infusion to the date of death from any cause.
| 2 years post CAR-T infusion |
| Objective remission rate (ORR) at 3-month | Objective remission rate (ORR) at 3-month is defined as the incidence of either a CR or a partial response (PR) at 3-month after CAR-T infusion per the Lugano Classification as determined by study investigators | 3 months post CAR-T infusion |
| Xuanwu Hospital Capital Medical University | Not yet recruiting | Beijing | China |
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| Sun Yat-Sen University Cancer Center | Not yet recruiting | Guangzhou | China |
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| Henan Cancer Hospital | Not yet recruiting | Henan | China |
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| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, | Not yet recruiting | Wuhan | China |
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