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

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.

NCT Number	NCT07542678
Lead Sponsor	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Collaborators: Universitätsklinikum Düsseldorf, Germany, Roche Pharma AG
Conditions	Relapsed /Refractory DLBCL
Enrollment	20 participants
Start Date	2026-04
Primary Completion	2028-04 (estimated)
Study Completion	2030-04 (estimated)
Updated on ClinicalTrials.gov	2026-04-21