Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy
Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy
ClinicalTrials.gov ID: NCT04703686
Sponsor: The Lymphoma Academic Research Organisation
Information provided by: The Lymphoma Academic Research Organisation (Responsible Party)
Last Update Posted: 2023-12-05
Brief 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
Official Title:
A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy
Intervention / Treatment:
- Drug: Obinutuzumab
- Drug: RO7082859
| Category | Value |
|---|---|
| Study Start (Actual) |
2021-03-30
|
| Primary Completion (Actual) |
2023-01-10
|
| Study Completion (Estimated) |
2026-03-01
|
| Enrollment (Actual) | 67 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
BiCAR
|