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Mantle Cell LymphomaPhase 2NCT07799220

A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma

A Phase 2 study testing Zanubrutinib, Obinutuzumab and Sonrotoclax in people with Mantle Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The researchers are doing this study to find out whether the combination of zanubrutinib, obinutuzumab, and sonrotoclax (BOSon) is an effective treatment approach for people with mantle cell lymphoma (MCL). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Zanubrutinib, Obinutuzumab and Sonrotoclax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesUnited States
Study dates
Dec 2026to Sep 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documentation of disease: Patients must have pathologically confirmed MCL at the treating institution
  • Evaluable disease, stage II-IV
  • o Patients with non-nodal leukemic MCL may enroll even without FDG PET/CT measurable disease; an end-of-treatment BMBx to confirm response is required in such cases
  • Age ≥ 65 years at screening
  • If Age <65, then required to fulfill one of the following criteria disqualifying for autologous transplant (autoHCT):
  • Comorbid disease(s) such as CAD, heart failure, pulmonary dysfunction, liver, or kidney dysfunction that precludes autoHCT based on expected increased morbidity
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  • ECOG ≥ 2 (Appendix 1) due to comorbidities
  • Ejection fraction ≥ 35% and <45%
  • Impaired pulmonary function test with DLCO <50% of expected
  • Medical conditions that in the opinion of the treating physician in consultation with the MSK PI or Co-PI preclude autoHCT
  • Not pregnant and not nursing
  • Required organ function:
  • o Adequate hematologic function, defined as:
  • Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 or >= 500 cells/mm3 if cytopenia is related to MCL (bone marrow involvement)
  • Platelets ≥ 75,000 cells/mm3 or 25,000 if related to MCL
  • Hemoglobin ≥ 9 g/dL or 8 g/dL if related to MCL
  • Adequate renal function defined as follows:
  • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  • o Adequate hepatic function defined as follows:
  • Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN; patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may enroll)
  • AST and ALT ≤ 2 x institutional ULN
  • Adequate cardiac function defined as follows:
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
  • To be eligible for this trial, patients should be class 2B or better (see Appendix 2: New York Heart Association (NYHA) Functional Classification).
  • No myocardial infarction within 6 months of screening
  • No unstable angina within 3 months of screening
  • No history of life-threatening arrhythmias
  • No CVA within 6 months from C1D1 Patient or healthcare proxy must be able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
  • HIV infection: Patients with a history of HIV infection that is well controlled on antiretroviral therapy are eligible if all of the following criteria are met: (1) undetectable HIV viral load by standard clinical assay AND (2) CD4+ T cell count of ≥200 cells/microliter. NOTE: Many HIV treatment regimens have the potential for drug-drug interactions; concomitant antiretroviral therapy should be cleared by a clinical pharmacist and approved by the site PI.
  • Hepatitis B: Patients with occult or prior HBV infection (defined as positive total hepatitis B core antibody [HBcAb] and negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to take appropriate anti-viral prophylaxis as indicated and undergo monthly DNA testing per SOP
  • Hepatitis C: Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA

Who cannot join

  • Active infection requiring parenteral antibiotic(s)
  • History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • Patients unable to swallow capsules or those with disease(s) or conditions significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic/active inflammatory bowel disease, or partial or complete bowel obstruction
  • Patients undergoing major surgery within 4 weeks of the first dose of study drug
  • Patients with ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures
  • Patients receiving treatment with any moderate or strong CYP3A4 inhibitor or moderate or strong CYP3A4 inducer ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug or requiring ongoing treatment with a moderate or strong CYP3A inhibitor or a moderate or strong CYP3A inducer are ineligible
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  • Concurrent participation in another therapeutic clinical trial
  • Patients with a prior or concurrent malignancy except for those whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Concomitant Medications: Concomitant medications use should only exclude patients from trial participation when clinically relevant known or predicted drug-drug interactions (see Section 5, Appendix 8) or potential overlapping toxicities will impact safety or efficacy.
  • o The following are exclusionary: receiving treatment with any moderate or strong CYP3A4 inhibitor or moderate or strong CYP3A4 inducer ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug or requiring ongoing treatment with a moderate or strong CYP3A inhibitor or a moderate or strong CYP3A inducer.
  • History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
  • Prior treatment:
  • Previous systemic therapy is prohibited
  • Systemic steroids are allowed for urgent disease control, improvement of performance status, or non-cancer indications
  • Must be <14 days' duration and ≤ 100 mg/day prednisone equivalent
  • Steroids must be discontinued prior to C1D1 study treatment
  • Inhaled, topical, and replacement/stress steroids are permitted

Trial locations and contacts

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

Zachary Epstein-Peterson, MD contact

646-608-4176

epsteinz@mskcc.org

Anita Kumar, MD contact

646-608-3780

7 sites in 1 country

United States7 sites

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

    Basking Ridge, New Jersey, 07920

    Zachary Epstein-Peterson, MD, 646-608-4176

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

    Commack, New York, 11725

    Zachary Epstein-Peterson, MD, 646-608-4176

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Zachary Epstein-Peterson, MD, 646-608-4176

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Zachary Epstein-Peterson, MD, 646-608-4176

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Zachary Epstein-Peterson, MD, 646-608-4176

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Zachary Epstein-Peterson, MD, 646-608-4176

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Zachary Epstein-Peterson, MD, 646-608-4176

Other trials in United States

About this study

Official title: A Phase II Study of MRD-guided Zanubrutinib, Obinutuzumab, and Sonrotoclax (BOSon) for Previously Untreated Transplant-ineligible Patients With Mantle Cell Lymphoma

The researchers are doing this study to find out whether the combination of zanubrutinib, obinutuzumab, and sonrotoclax (BOSon) is an effective treatment approach for people with mantle cell lymphoma (MCL).

Being tested
Zanubrutinib, Obinutuzumab, Sonrotoclax
Keywords
Zanubrutinib, Obinutuzumab, Sonrotoclax (BOSon), stage II-IV, 26-286
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.

  • ZanubrutinibDrug

    PO twice daily of each 28-day cycle

  • ObinutuzumabDrug

    IVPB on days 1, 8, and 15 of cycle 1; and IVPB on day 1 of cycles 2-8

  • SonrotoclaxDrug

    Sonrotoclax will be initiated on C2D1 using the ramp-up schedule

Study groups in NCT07799220
Study groupRoleWhat they receive
Zanubrutinib, Obinutuzumab, and SonrotoclaxExperimentalZanubrutinib will be administered PO twice daily of each 28-day cycle. Obinutuzumab will be administered on days 1, 8, and 15 of cycle 1 and IVPB on day 1 of cycles 2-8. Sonrotoclax will be initiated on C2D1 using the ramp-up schedule.
Receives: Drug: Zanubrutinib; Drug: Obinutuzumab; Drug: Sonrotoclax

What is being measured

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

  1. evaluate BOSon

    through determination of the PET CR-uMRD6 rate

    Measured: up to 3 years

Secondary outcomes (1)

  1. Proportion of Participants with Tumor Lysis Syndrome (TLS)

    per Howard criteria

    Measured: up to 3 years

Timeline

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

  1. First posted2 Sep 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a multicenter phase II study of zanubrutinib, obinutuzumab, and sonrotoclax (BOSon) as frontline therapy for transplant-ineligible patients with mantle cell lymphoma (MCL).
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799220
Sponsor's protocol ID
26-286
Status last verified
Nov 2026
First submitted
26 Aug 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanubrutinib, Obinutuzumab and Sonrotoclax in people with Mantle Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 7 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 31 inclusion and 17 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 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 Zachary Epstein-Peterson, MD (646-608-4176, epsteinz@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluate BOSon (time frame: up to 3 years). 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 NCT07799220.

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 4 Nov 2026.

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