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

NCT07460362 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-03-10

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Glofitamab

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.

DRUG

Lenalidomide

Lenalidomide is an agent with immunomodulatory and anti-angiogenic properties which confer multiple antitumor effects.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2027-12-30
Completion
2029-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07460362 on ClinicalTrials.gov