drugset / Trial / NCT07542678

Double-T - Improving Outcomes in High-risk 2nd Line Relapsed/Refractory Large B-Cell Lymphoma Patients Eligible for CAR-T-cell Therapy With a Glofitamab-based Induction and Consolidation Concept

NCT07542678

NaSingle-groupOpen-labelTreatment

Summary

The Double-T trial is a prospective, randomized, single-arm, open-label, multicenter phase II trial investigating a double T-cell therapy strategy, which includes glofitamab with gemcitabine/oxaliplatin (Glofi-Gem/Ox) prior to and glofitamab monotherapy consolidation after standard of care Chimeric Antigen Receptor (CAR)-T cell therapy in high-risk 2nd line relapsed/refractory Large B-Cell Lymphoma (r/r LBCL) patients. Data on safety, efficacy, and quality of life (QoL) will be collected and analyzed.

Timeline

Start
2026-04
Primary completion
2028-04
Completion
2030-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule
Subject Glofitamab Monoclonal antibody
Subject Oxaliplatin Small molecule