NCT07460362

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The goal of this clinical study is to evaluate the efficacy of glofitamab combined with lenalidomide in high-risk patients with R/R MCL previously treated with a BTK Inhibitor. The main questions it aims to answer are: 1. 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. 2. the efficacy of glofitamab combined with lenalidomide in Chinese high-risk patients with R/R MCL, including complete response rate (CRR) at C6 and the end of induction, overall response rate at C6 and the end of induction, best response of complete response (BOCR) . 3. the safety profiles of Glofitamab combined with lenalidomide in the treatment of high-risk mantle cell lymphoma. 4. the potential biomarkers which can predict efficacy and safety of Glofitamab combined lenalidomide in Chinese adult patients with relapsed/refractory high risk mantle cell lymphoma, including circulating tumor DNA (ctDNA), total metabolic tumor volume (TMTV), etc.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-12-30
• Completion: 2029-12-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: China