NCT04703686

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

A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diffuse Large B-Cell Lymphoma Refractory
• Refractory Indolent Adult Non-Hodgkin Lymphoma
• Refractory Transformed B-cell Non-Hodgkin Lymphoma
• Refractory Primary Mediastinal Large B-Cell Cell Lymphoma
• Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	1000mg - prephase - one infusion at D-3
DRUG	RO7082859	2.5 mg D1C1, 10 mg D3C1, then 30 mg D8C1 and D1 every 21 days (C2-C11, D1C2 starts 14 days after D1C1)

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-01-10
• Completion: 2025-05-21
• First posted: 2021-01-11
• Last updated: 2026-03-16

Locations

19 sites across 1 country: France