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NOT YET RECRUITING
NCT07542678
PHASE2

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

Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04

Completion Date

2030-04

Last Updated

2026-04-21

Healthy Volunteers

No

Interventions

DRUG

Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy

Induction Therapy before Standard of Care CAR-T Cell therapy

DRUG

Glofitamab as Consolidation therapy

Consolidation with Glofitamab after CAR-T Cell Therapy

Locations (5)

Universitätsklinikum Heidelberg - Innere Medizin V

Heidelberg, Baden-Wurttemberg, Germany

Universitätsklinikum Düsseldorf - Klinik für Hämatologie, Onkologie und klinische Immunologie

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Essen (AöR) - Westdeutsches Tumorzentrum Essen - Klinik für Hämatologie und Stammzellltransplantation

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Münster - Medizinische Klinik A

Münster, North Rhine-Westphalia, Germany

Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

Berlin, State of Berlin, Germany