NCT07460362 Lenalidomide Mantle cell lymphoma refractory Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07460362 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07460362 is a hot trial to watch

Mantle cell lymphoma refractory is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07460362 is notable because it evaluates Lenalidomide in a Phase 2 design sponsored by Peking University Third Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

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.

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 43 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• 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. (24 months) — 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, defined as the percent of patients who achieve a best complete response (CR) or partial response (PR) according to the 2014 Lugano response criteria for non-Hodgkin lymphoma at the end of induction.

Readout outlook and evidence gap

The current protocol points to 2027-12-30 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Lenalidomide is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: Peking University Third Hospital is resolved to a normalized organization record in Beijing Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07460362 provides a focused lens on Mantle cell lymphoma refractory development. Its value will be determined by whether Lenalidomide can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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