ClinicalTrials.gg
Not yet recruitingNCT07799220Updated Nov 4, 2026

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

A Phase 2 interventional study of Zanubrutinib and Obinutuzumab in Mantle Cell Lymphoma, sponsored by Memorial Sloan Kettering Cancer Center. Not yet recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Updated Nov 4, 2026Start date moved1 site added+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Mantle Cell Lymphoma

Keywords

  • Zanubrutinib
  • Obinutuzumab
  • Sonrotoclax (BOSon)
  • stage II-IV
  • 26-286
03

In context

Lymphoma, Mantle-Cell

1,220 studies on the registry are indexed under Lymphoma, Mantle-Cell; 154 are open to participants now.

This study's planned enrollment of 45 is above the median of 37 across 1,001 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Documentation of disease: Patients must have 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 ; 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 transplant (autoHCT):

    • Comorbid disease(s) such as CAD, heart failure, pulmonary dysfunction, liver, or kidney dysfunction that precludes autoHCT based on expected increased morbidity
    • ≥ 2 (Appendix 1) due to comorbidities
    • ≥ 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:

  • (ANC) ≥ 1000 cells/mm3 or >= 500 cells/mm3 if cytopenia is related to MCL (bone marrow involvement)
  • ≥ 75,000 cells/mm3 or 25,000 if related to MCL
  • ≥ 9 g/dL or 8 g/dL if related to MCL

Adequate renal function defined as follows:

  • (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula

    o Adequate hepatic function defined as follows:

  • Total ≤ 2.0 x institutional (ULN; patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may enroll)
  • 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 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 and can understand and agree to comply with the requirements of the study and the schedule of assessments
  • 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) 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.
  • : 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
  • : Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA

Exclusion criteria

Exclusion Criteria:

  • 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 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
  • Concurrent participation in another therapeutic clinical trial
  • Patients with a prior or concurrent except for those whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen
  • Concomitant Medications: Concomitant medications use should only exclude patients from trial participation when 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 ).
  • Prior treatment:

    • Previous systemic therapy is prohibited
    • Systemic 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
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Zanubrutinib, Obinutuzumab, and Sonrotoclax

    Zanubrutinib 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.

    Drug: Zanubrutinib · Drug: Obinutuzumab · Drug: Sonrotoclax

Interventions

  • PO twice daily of each 28-day cycle

  • IVPB 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

06

What researchers measure

Primary outcomes

  1. evaluate BOSon

    through determination of the PET CR-uMRD6 rate

    Time frame: up to 3 years

Secondary outcomes

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

    per Howard criteria

    Time frame: up to 3 years

07

Study locations

7 sites
  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activites)
    Commack, New York 11725, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    New York, New York 10065, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    • Zachary Epstein-Peterson, MD · Contact646-608-4176
08

References and documents

Individual participant data

Plan to share: Yes

Access criteria: 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Sep 2028, 21 months later.

Of 153 non-industry phase 2 interventional studies under Lymphoma, Mantle-Cell, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 108. This study's planned 21 months is below that.

Counting every sponsor, half of 183 studies reached it within 63 months; a quarter within 38 and three quarters within 106.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 4, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2026
First posted
Sep 2, 2026
StartEst.
Dec 2026was Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, United States
Show 1 removed
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · East White Plains, United States
Nov 4, 2026
Start date
Sep 2026→Dec 2026
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site added, 1 site removed
    Show site
    • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, United States
    Show 1 removed
    • Memorial Sloan Kettering Westchester (Limited Protocol Activities) · East White Plains, United States
    Start date Sep 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07799220
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Dec 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Zachary Epstein-Peterson, MD
Contact
epsteinz@mskcc.org
646-608-4176
Anita Kumar, MD
Contact
646-608-3780
Zachary Epstein-Peterson, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drugs tested here: Zanubrutinib · Obinutuzumab · Sonrotoclax

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