drugset / Trial / NCT04703686

Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

NCT04703686

Phase 2 Completed 67 enrolled The Lymphoma Academic Research Organisation
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

EvaluationDrugModalityDoseRoute
Subject Glofitamab Monoclonal antibody 30 mg Intravenous
Background Obinutuzumab Monoclonal antibody 1000 mg