drugset / Trial / NCT04703686
Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy
NaSingle-groupOpen-labelTreatment
Summary
This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy: * cohort 1: DLBCL patients * cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial. Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab. The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy
Timeline
- Start
- 2021-03-30
- Primary completion
- 2023-01-10
- Completion
- 2025-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glofitamab | Monoclonal antibody | 30 mg | Intravenous |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | — |