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
Phase 2
Not yet recruiting
20 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Roche Pharma AG · collabUniversitätsklinikum Düsseldorf, Germany · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Glofitamab | Monoclonal antibody | — | — |
| Subject | Oxaliplatin | Small molecule | — | — |