Relmacabtagene Autoleucel Injection Followed by Tislelizumab for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Involved in the Central Nervous System
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.
• 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:
‣ Neutrophil count (anc) ≥1.0 x 109/L;
⁃ Hemoglobin ≥ 8.0 g/dl;
⁃ Platelet count ≥ 50 x 109/L;
⁃ Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
⁃ Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 x ULN or ≤ 5 x ULN (in the presence of hepatic invasion);
⁃ Creatinine clearance ≥40mL/min
⁃ Lipase ≤ 1.5 x ULN