Changeflow GovPing Healthcare & Life Sciences Double-T Phase 2 Trial of Glofitamab for Relaps...
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Double-T Phase 2 Trial of Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma

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Summary

NIH registered Phase 2 clinical trial NCT07542678 (Double-T) on ClinicalTrials.gov, investigating a glofitamab-based double T-cell therapy strategy in high-risk relapsed/refractory large B-cell lymphoma patients eligible for CAR-T cell therapy. The trial will collect safety, efficacy, and quality of life data across induction and consolidation phases.

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What changed

NIH published a clinical trial registration for the Double-T study, a prospective, randomized, open-label, multicenter Phase II trial. The trial evaluates a double T-cell therapy strategy combining glofitamab with gemcitabine/oxaliplatin as induction therapy followed by glofitamab monotherapy consolidation after standard CAR-T cell therapy in high-risk second-line relapsed/refractory large B-cell lymphoma patients. Conditions, interventions, and study milestones are listed.

Healthcare providers and clinical investigators participating in CAR-T or lymphoma research programs should note this trial's inclusion criteria and intervention arms. The trial is registered with NIH as the sponsor, and study data will be collected prospectively across multiple centers.

Archived snapshot

Apr 22, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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 NCT07542678 Kind: PHASE2 Apr 21, 2026

Abstract

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: Glofitamab, Gemcitabine, and Oxaliplatin as Induction Therapy, Glofitamab as Consolidation therapy

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Last updated

Classification

Agency
NIH
Published
April 21st, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Clinical investigators Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial conduct Drug therapy research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Medical Devices

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