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MCLPhase 2NCT07460362

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

A Phase 2 study testing Glofitamab and Lenalidomide in people with MCL and Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by Peking University Third Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Glofitamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
11 Aug 2025to 30 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • Signed Informed Consent Forms
  • Age: >= 18 to 80 years
  • Eastern Cooperative Oncology Group =< 2
  • Diagnosis of MCL established by histologic assessment
  • Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma.
  • Prior therapy have included a BTK inhibitor, including ibrutinib, zanubrutinib, obrutinib, acalabrutinib and various BTKi in clinical trials. BTki exposure is required, which include BTKi failure or intolerance. BTKi failure is defined as progression of disease during BTKi therapy or patients have progressed or relapsed after completing BTK inhibitor therapy
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  • At least one high risk features as classified:
  • Blastoid/pleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion
  • Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography [CT] scan）
  • Patients that did not achieve a CR with their first-line treatment
  • early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines
  • Measurable lesions on cross-sectional imaging documented by diagnostic imaging(MRI, CT or PET-CT), （GTD）≥1.5 cm
  • Adequate liver function : Total bilirubin =< 3 x upper limit of normal (ULN) (unless has Gilbert's disease), Aspartate aminotransferase (AST) =< 5.0 x ULN, Alanine aminotransferase (ALT) =< 5.0 x ULN

Who cannot join

  • • Already enrolled in other Ongoing interventional or non-interventional R/R MCL clinical trials;
  • Currently receiving immunosuppressive treatment for other diseases;
  • Previous treatment with lenalidomide;
  • Combined with other malignant tumors within 3 years;
  • The researcher determines that they are not suitable to participate in this study;
  • Serious mental or neurological disorders that affect informed consent and/or the expression or observation of adverse reactions;
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  • Have a history of major or extensive cardiovascular disease, such as New York Heart Association class III or Grade IV heart disease or objective assessment, myocardial infarction, unstable arrhythmia or unstable angina within 6 months before the first cycle;
  • Recent major surgery (within 4 weeks before the start of the first cycle);
  • Active autoimmune diseases with poor treatment control;
  • Any active infection that may affect the safety of the participant, including bacterial, fungal and various viral infections, occurred within 7 days before the first day of cycle 1;
  • Positive SARS-CoV-2 PCR test within 7 days prior to enrollment
  • Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.
  • Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • A history of severe deep vein thrombosis event or pulmonary embolism within 6 months
  • Patient follow-up was not possible.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hongmei Jing contact

86 010-82266781

hongmei_jing@163.com

China1 site, 1 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Hongmei Jing, 010-82266778, hongmei_jing@163.com

    Recruiting

Other trials in China

About this study

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

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.

Read more

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.

Read the 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.
Being tested
Glofitamab, Lenalidomide
Keywords
Relapsed or Refractory MCL, previously treated with a BTK Inhibitor
Medical subject headings
Recurrence, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    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.

  • LenalidomideDrug

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

Study groups in NCT07460362
Study groupRoleWhat they receive
high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTKiExperimentalAt least one high risk features as classified: * Blastoid/pleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion * Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography [CT] scan） * Patients that did not achieve a CR with their first-line treatment * early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines
Receives: Drug: Glofitamab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 24 months

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    ORR, defined as the proportion of patients with overall response rate at C6 and the end of induction, as determined by the investigator using 2014 Lugano Response Criteria.

    Measured: up to 24 months

  2. complete response rate (CRR)

    CRR, defined as the proportion of patients with complete response rate（CRR）at C6 and the end of induction, and a best overall response of CR at any time during the studas determined by the investigator using 2014 Lugano Response Criteria.

    Measured: Up to 24 months

  3. Duration of Response (DoR)

    DoR, defined as the time from the first occurrence of a documented objective response (PR or CR) to disease progression or death from any cause (whichever occurs first) according to the 2014 Lugano Response Criteria, as determined by the investigator.

    Measured: Up to 48 months

  4. Duration of Complete Response (DoCR)

    DoCR, defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first according to the 2014 Lugano Response Criteria, as determined by the investigator.

    Measured: Up to 48 months

  5. Progression-Free Survival (PFS)

    PFS, defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator using 2014 Lugano Response Criteria.

    Measured: Up to 48 months

  6. Overall Survival (OS)

    OS, defined as the time from the first study treatment to the date of death from any cause.

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start11 Aug 2025
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07460362
Sponsor's protocol ID
ML45833
Status last verified
Feb 2026
First submitted
15 Feb 2025
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glofitamab and Lenalidomide in people with MCL and Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hongmei Jing (86 010-82266781, hongmei_jing@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07460362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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