RecruitingPhase 2NCT07460362

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

Sponsor

Peking University Third Hospital

Enrollment

43 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

MCL Relapsed or Refractory Mantle Cell Lymphoma (MCL)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — glofitamab (an immunotherapy that helps your immune system attack cancer cells) and lenalidomide (an immune-modulating drug) — for people with a type of blood cancer called mantle cell lymphoma that has come back or stopped responding to treatment. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with mantle cell lymphoma - You have already received at least one prior treatment, including a BTK inhibitor drug - Your cancer has high-risk features such as aggressive cell appearance, fast-growing cells (Ki67 ≥50%), or certain gene mutations (TP53) - You are reasonably functional (able to care for yourself) **You may NOT be eligible if...** - You have never been treated with a BTK inhibitor - You have serious organ problems or other active cancers - You do not meet other health and lab requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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