drugset / Trial / NCT06876688

Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma

NCT06876688

Phase 2 Recruiting 30 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-11-30
Primary completion
2028-11-30
Completion
2028-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Relmacabtagene Autoleucel Cell therapy
Subject Tislelizumab Monoclonal antibody 200 mg Intravenous

Indications