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Mantle Cell LymphomaPhase 1NCT06192888

A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma

A Phase 1 study testing Glofitamab, Obinutuzumab and Lenalidomide in people with Mantle Cell Lymphoma and MCL, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma, MCL
What is being tested?
Glofitamab, Obinutuzumab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
10 sitesUnited States
Study dates
8 Jan 2024to 8 Jan 2028
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at the time of signing Informed Consent
  • ECOG 0-2
  • Histologic diagnosis confirmed as relapsed/refractory mantle cell lymphoma according to WHO guidelines, confirmed by the pathology department at the treating institution
  • If the patient previously received CD20 directed therapy, there must be evidence of CD20 expression on neoplastic cells according to instutitional pathology department guidelines. This must be confirmed on a biopsy of Relapsed/Refractory Mantle Cell Lymphoma performed after receipt of the last CD20 directed therapy.
  • At minimum 10 unstained slides or tissue block from tumor containing FFPE biospecimen sample from a Relapsed/Refractory Mantle Cell Lymphoma biopsy is required for tumor genomic profiling and MRD testing. If adequate archival tissue is not available, then a repeat biopsy will be required. This requirement can be waived (i.e. if site of disease is inaccessible) after discussion with the MSKCC Principal Investigator
  • Tumor genomic profiling from a biopsy sample collected within 6 months of signing informed consent form is required. For MSK patients, this will be done via MSK IRB#12-245 (Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT)) within 6 months prior to signing Informed Consent form, and preferably repeated for patients who did not have IMPACT performed after discontinuing their last line of treatment. Patients at external sites will run genomic profiling per institutional guidelines. If sites do not have an approved assay available, they may send archival tissue to MSK. Details included in lab manual
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  • Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma. Prior BTKi failure is required. BTKi failure is defined as progression of disease during BTKi therapy or patients must have progressed or relapsed after completing BTK inhibitor therapy, or failed to achieve a PR following 12 weeks of BTK inhibitor therapy.
  • Presence of evaluable disease
  • Adequate bone marrow and organ function:
  • Absolute neutrophil count (ANC) ≥1,000 cells/mcL, unless felt to be secondary to underlying MCL (minimum ANC 500 cells/mcL)
  • Hgb ≥ 8 g/dL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum Hgb 7.0 g/dL) without transfusional support for 7 days before first treatment)
  • Platelet count ≥50,000 cells/mcL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum platelet count 25,000 cells/mcL) without transfusional support for 7 days before first treatment)
  • Renal function assessed by calculated Cockcroft-Gault creatinine clearance (CrCl; see Appendix A) ≥ 30 ml/min. See lenalidomide Treatment Plan, (Table 10-1), for lenalidomide dose adjustment for CrCl ≥ 30 mL/min and < 60 mL/min
  • Adequate hepatic function as determined by:
  • Total bilirubin ≤1.5X upper limit of normal (ULN) unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 x ULN
  • Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN or ≤ 5 x ULN in cases of documented liver involvement.
  • Willingness to receive adequate prophylaxis and/or therapy for thromboembolic events, unless contraindicated in the opinion of the investigator.
  • Willingness to undergo confirmatory procedures for assessment of disease status and experimental studies as required by protocol, including bone marrow (BM) aspiration/biopsy and gastrointestinal endoscopy/colonoscopy with biopsy, and/or biopsy of other tissue when appropriate and medically feasible.
  • Each patient must sign an informed consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate.Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be eligible.
  • Willingness of patients who can become pregnant, according to Revlimid/lenalidomide Risk Evaluation and Mitigation Strategy (REMS) criteria, to undergo pregnancy testing in accordance with REMS requirements
  • Willingness of all patients to complete surveys and adhere to contraception requirements mandated by the Revlimid/lenalidomide REMS
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 2 months after the final dose of glofitamab, 28 days after the last dose of lenalidomide, 18 months after the last dose of obinutuzumab.
  • For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of lenalidomide, 6 months after the last dose of obinutuzumab. Men must refrain from donating sperm during this same period.
  • Life expectancy ≥ 12 weeks as determined by patient's primary clinician

Who cannot join

  • Investigational agent or anticancer therapy within 5 half-lives prior to start of study therapy except therapeutic monoclonal antibody treatment must be discontinued a minimum of 4 weeks prior to study therapy. An exception is BTKi therapy, which can be continued to prevent disease flare up until 1 day prior to start of study therapy.
  • Major surgery within 4 weeks prior to planned start of study therapy.
  • Radiotherapy within 7 days of the start of study therapy.
  • CART infusion within 30 days prior to Day 1 of Cycle 1
  • Active hepatitis B or C, as defined below:
  • HBV surface antigen positive
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  • HBV surface antigen negative, HBV core antibody positive and detectable HBV viral DNA. Note: subjects who are HBV core antibody positive and viral DNA negative are eligible. (Prophylactic anti-viral treatment is required for subjects who are HBV core antibody positive)
  • HCV antibody positive and HCV RNA positive.
  • History of human immunodeficiency virus (HIV) unless all of the following criteria are met:
  • CD4+ T cell count ≥ 250 cells/mcL
  • No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 1 year prior to signing Informed Consent Form
  • Stable (no change in regimen for ≥ 4 weeks) and effective antiretroviral regimen, and HIV viral load < 400 copies/mL within 4 weeks prior to signing Informed Consent form
  • Active concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix or breast, adequately treated lentigo maligna melanoma, or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy previously treated for curative intent is permitted.
  • Pregnant or lactating, intending to become pregnant, or unable/unwilling to comply with pregnancy testing and birth control measures and REMS enrollment, as described in inclusion criteria.
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1.
  • Clinically significant history of liver disease, including active viral or other hepatitis or current uncontrolled alcohol use disorder that would compromise patient's ability to safely participate in the trial, per clinician's judgment
  • Active central nervous system (CNS) involvement with lymphoma, either parenchymal or leptomeningeal
  • Presence of ≥Grade 2 toxicity (CTCAE v5.0) due to prior cancer therapy
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
  • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
  • History of hypersensitivity to compounds of similar biological or chemical composition to IMiDs® and/or the excipients contained in the study drug formulations
  • Previous treatment with bispecific antibody therapy directed against CD20 and CD3
  • Previous treatment with lenalidomide or other IMiDs® within 12 months of treatment initiation on this study.
  • Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy
  • Autologous stem cell transplantation (ASCT) within the period ≤3 months prior to the signing of the informed consent form. Patients with a more distant history of ASCT must exhibit full hematologic recovery before enrollment into the study
  • Allogenic stem cell transplantation within the period of ≤3 months prior to signing of the Informed Consent form, evidence of graft-versus-host-disease (GVHD), or receiving active immunosuppression for GVHD.
  • A history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
  • Concurrently use other anticancer or experimental treatments
  • Administration of a live vaccine within 28 days prior to the start of study treatment (Cycle 1 Day 1).
  • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment
  • Corticosteroid therapy within 2 weeks prior to first dose of study treatment, with the following exceptions:
  • Short course systemic corticosteroids (total daily dose equivalent of prednisone 100mg or dexamethasone 20 mg) is permissible for disease control, improvement of performance status, or non-cancer indication if administered for ≤ 5 days, and must be discontinued prior to study initiation of study treatment. When clinically indicatedfeasible, tumor assessments such as imaging and biopsies should be performed prior to steroid administration, though this is not required for enrollment.
  • Chronic corticosteroid use of ≤20 mg prednisone equivalent per day, on a stable dose for ≥4 weeks prior to registration.
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety, or affect compliance with the protocol or interpretation of results.
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV or Objective Assessment Class C or D cardiac disease, myocardial infarction ≤ 6 months from registration, symptomatic congestive heart failure, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
  • Known or suspected chronic active Epstein-Barr viral (CAEBV) infection or reactivation of a latent infection prior to enrollment. CAEBV is a progressive disease with markedly elevated levels of EBV DNA in the blood and infiltration of organs by EBV-positive lymphocytes along with fever, lymphadenopathy, splenomegaly, EBV hepatitis and/or pancytopenia.
  • Participants with detectable EBV titers (quantified using Real-Time qPCR) that are below the level of quantification are eligible.
  • Participants with an EBV titer of <500 IU/mL are eligible, provided that levels are measured monthly for the first 3 months. If there is a rise in EBV levels >500 IU/mL during treatment, management and any therapy should follow local guidelines.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Dana Farber Cancer Institute (Data Collection and Specimen Analysis)

    Boston, Massachusetts, 02115

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited protocol activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

  • Mayo Clinic (Data Collection Only)

    Rochester, Minnesota, 55905

  • Memorial Sloan Kettering Nassau (All protocol activities)

    Rockville Centre, New York, 11553

  • Washington University (Data Collection Only)

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Pilot Study of Glofitamab and Lenalidomide in Patients With Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With a BTK Inhibitor

The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma

Being tested
Glofitamab, Obinutuzumab, Lenalidomide
Keywords
Mantle Cell Lymphoma, MCL, Memorial Sloan Kettering Cancer Center, 23-319
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

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

Study groups in NCT06192888
Study groupRoleWhat they receive
Participants with Mantle Cell LymphomaExperimentalParticipants will be diagnosed with relapsed, refractory (R/R) mantle cell lymphoma (MCL) with prior BTK inhibitor (BTKi) failure
Receives: Drug: Glofitamab; Drug: Obinutuzumab; Drug: Lenalidomide

What is being measured

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

  1. Proportion of participants who successfully receive glofitamab

    Treatment feasibility defined as the proportion of participants who successfully receive glofitamab during cycles 1-3 without any dose delays of glofitamab for greater than 7 days

    Measured: 1 year

Timeline

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

  1. First posted5 Jan 2024
  2. Study start8 Jan 2024
  3. Primary completion8 Jan 2028 (estimated)
  4. Study completion8 Jan 2028 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06192888
Sponsor's protocol ID
23-319
Status last verified
Mar 2026
First submitted
21 Dec 2023
Last updated
27 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Glofitamab, Obinutuzumab and Lenalidomide in people with Mantle Cell Lymphoma and MCL, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

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 24 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 27 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 10 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who successfully receive glofitamab (time frame: 1 year). 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 NCT06192888.

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 27 Mar 2026.

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