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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Relapsed /Refractory DLBCL

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

Sponsors & Collaborators

  • Universitätsklinikum Düsseldorf, Germany

    collaborator UNKNOWN

  • Roche Pharma AG

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Sascha Dietrich, Prof. Dr. · University Düsseldorf

  • Salah-Eddin Al-Batran, Prof. Dr. · Frankfurter Institut für Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2030-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542678 on ClinicalTrials.gov