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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Beljing Tiantan Hospital, Capttal Medical, University
Beijing, China
NOT_YET_RECRUITINGXuanwu Hospital Capital Medical University
Beijing, China
NOT_YET_RECRUITINGSun Yat-Sen University Cancer Center
Guangzhou, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Henan, China
NOT_YET_RECRUITINGRuijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, China
NOT_YET_RECRUITINGComplete 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.
Time frame: 3 months post CAR-T infusion
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.
Time frame: 2 years post CAR-T infusion
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death from any cause.
Time frame: 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
Time frame: 3 months post CAR-T infusion
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