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NCT06271057

Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse

Recruiting now Phase 2 Last updated 15 October 2024
What this trial tests

Phase 2 trial testing golcadomide in Diffuse Large B-cell Lymphoma Refractory in 65 participants. Currently enrolling.

Timeline
14 June 2024
Primary endpoint
15 January 2026
20 October 2027

Quick facts

Lead sponsorThe Lymphoma Academic Research Organisation
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment65
Start date14 June 2024
Primary completion15 January 2026
Estimated completion20 October 2027
Sites13 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

The Lymphoma Academic Research Organisation — full company profile →

Who can join

18 and older, any sex, with Diffuse Large B-cell Lymphoma Refractory or Refractory Primary Mediastinal Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study. The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion. The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeted protein degradation: advances in drug discovery and clinical practice.
    Zhong G, Chang X, Xie W, Zhou X. · · 2024 · cited 112× · PMID 39500878 · DOI 10.1038/s41392-024-02004-x
  2. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
    Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
  3. 2026 Update on the Management of Diffuse Large B-Cell Lymphoma.
    Chong EA, Tomasulo EB, Barta SK. · · 2026 · PMID 41654318 · DOI 10.1002/ajh.70229

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Other trials of golcadomide

Trials testing the same drug.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06271057.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing