drugset
drugset / Trial / NCT05364424

A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

NCT05364424 ↗

Phase 1 Completed 43 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the preliminary efficacy, safety, and pharmacokinetics of glofitamab (glofit) in combination with rituximab plus ifosfamide, carboplatin, and etoposide (R-ICE) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have failed one prior line of therapy incorporating an anti-cluster of differentiation (CD) 20 antibody (i.e., rituximab) and an anthracycline, and who are transplant or chimeric antigen receptor T-cell (CAR-T) therapy eligible, defined as being medically eligible for intensive platinum-based salvage therapy followed by autologous stem cell transplantation (ASCT) or for CAR-T therapy.

Timeline

Start
2022-11-04
Primary completion
2025-10-15
Completion
2025-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Glofitamab Monoclonal antibody — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Etoposide Small molecule — Intravenous
Background Ifosfamide Small molecule — Intravenous
Background Obinutuzumab Monoclonal antibody — Intravenous
Background Rituximab Monoclonal antibody — Intravenous
Background Tocilizumab Monoclonal antibody — Intravenous

Indications

diffuse large B-cell lymphoma