RecruitingPhase 2NCT06876688

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

Relmacabtagene Autoleucel Injection Followed by Tislelizumab for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma Involved in the Central Nervous System

Sponsor

Ruijin Hospital

Enrollment

30 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

CNS Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment sequence using relma-cel (a CAR-T cell therapy that targets CD19) followed by tislelizumab (an immunotherapy drug) in patients with large B-cell lymphoma that has spread to the brain or central nervous system and has returned or not responded to prior treatment. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory large B-cell lymphoma with brain (CNS) involvement - Your cancer responded (complete or partial response) to salvage (rescue) therapy and is currently stable - You are in good to moderate general health (ECOG 0-2) - You are expected to live at least 12 weeks - Your blood counts and organ function meet minimum thresholds **You may NOT be eligible if...** - You have uncontrolled infection - You are pregnant or breastfeeding - You have significant organ problems preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelma-cel Followed by Tislelizumab

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.