Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor
Peking University Third Hospital
Study ID
NCT07460362
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • MCL
  • Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab is a human IgG1-bispecific antibody targeting CD20 expressed on the surface of B cells and CD3ɛ chain expressed on the surface of T cells.
  • Lenalidomide — DRUG
    Lenalidomide is an agent with immunomodulatory and anti-angiogenic properties which confer multiple antitumor effects.

Study Details

A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor. Patients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy. Glofitamab will be administered intravenously and lenalidomide will be self-administered orally. Obinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET/CT according to Lugano criteria during study enrolment. The primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.

Key Dates

Start date
Aug 11, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2029

Study Design

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

Arms

  • Experimental: high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTKi
    At least one high risk features as classified: * Blastoid/pleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion * Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography \[CT\] scan） * Patients that did not achieve a CR with their first-line treatment * early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines

Primary Outcome Measure

to evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL by best overall response rate (BOR) at the end of induction. [ Time Frame: 24 months ]

Central Contacts

Related Studies