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NOT YET RECRUITING
NCT07613788
PHASE2

Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.

Official title: A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-05

Completion Date

2029-04

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Rimegepant

Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.

DRUG

Glofitamab

Glofitamab will be administered intravenously with step-up dosing. Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.

DRUG

Obinutuzumab

Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.

BIOLOGICAL

CD19 CAR-T Cell Therapy

Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy. The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.

DRUG

Fludarabine

Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China