Relma-cel Followed by Tislelizumab for the Treatment of Relapsed/Refractory CNS Large B-Cell Lymphoma
ConditionCNS Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Severe active central nervous system symptoms
Prior chimeric antigen receptor cellular immunotherapy targeting cd19
Known human immunodeficiency virus (hiv) infection or positive immunoassay;
Live vaccination within 30 days prior to study drug administration;
Trial design
Treatments tested in this trial
- Relma-cel Followed by Tislelizumab
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov