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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT07453095
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab treatment in post CAR-T R/R MCL patients

Study Details

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.

Key Dates

First listed
Mar 5, 2026
Start date
Jun 5, 2026
Status verified
Jun 2026
Primary completion
Jul 15, 2028
Completion
Jun 15, 2030

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Patients enrolled and with confirmed eligibility will be treated according to the following schedule: * Obinutuzumab (2000 mg) will be administered 7 days before (Day 1, Cycle1) the first glofitamab dose; * Glofitamab treatment for 12 cycles: intravenous glofitamab will be administered with step-up dosing on D8 (2.5mg), D15 (10mg) of Cycle (C) 1 and at 30mg on D1 of C2-12 (21-day cycles).

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: 27 months ]

Central Contacts

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