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RECRUITING
NCT07460362
PHASE2

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

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2025-08-11

Completion Date

2029-12-30

Last Updated

2026-03-10

Healthy Volunteers

No

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.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China