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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Relma-cel Followed by Tislelizumab
DrugEnrolled 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete 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 infusionSecondary outcomes
1
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 infusion2
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 infusion3
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 infusionSponsors and contacts
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Source ClinicalTrials.gov