NCT07453095

Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy

A Phase II, Multicenter Study of GlOfitamab in Patients With Mantle Cell Lymphoma and inaDequate Response or Relapse Following CAR T-cell Therapy (GOLD)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy.

Detailed description

This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy. Patients experiencing failure after CAR-T cell treatment will be screened for inclusion and exclusion criteria for treatment and, if eligible, will enter the study. Safety events will be analyzed and compared with the previously described safety profile of glofitamab alone and other bispecific-containing regimens to exclude the risk of potential toxicity for all study participants. The study will include a period of screening phase, a period of treatment phase and a follow up phase.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Glofitamab	Glofitamab treatment in post CAR-T R/R MCL patients

Timeline

• Start date: 2026-04-15
• Primary completion: 2028-07-15
• Completion: 2030-06-15
• First posted: 2026-03-05
• Last updated: 2026-04-17

Locations

14 sites across 1 country: Italy