drugset / Trial / NCT07613788
Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05
- Primary completion
- 2028-11
- Completion
- 2029-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimegepant | Small molecule | 75 mg | Oral |
| Background | CD19-targeted CAR-T cells | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | Glofitamab | Monoclonal antibody | 30 mg | Intravenous |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |