New drug mosunetuzumab takes on rituximab in rare lymphoma trial
NCT ID NCT05886036
First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 14 times
Summary
This phase 2 trial tests whether mosunetuzumab, a newer antibody, works better than the standard rituximab for nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). About 70 patients with untreated or previously treated NLPHL will receive one of the two drugs. The main goal is to see which drug helps patients live longer without their cancer getting worse.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mosunetuzumab and rituximab (monoclonal antibodies)
- What this could lead to
- If mosunetuzumab works better than rituximab, it could offer a more effective treatment option for people with this rare lymphoma, potentially extending survival.
- What could go wrong
- This is a phase 2 trial with only 70 participants, so results are preliminary. Mosunetuzumab may not prove superior, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histopathologically confirmed diagnosis of NLPHL as confirmed by local pathologist's expert review. * Untreated NLPHL: stage IB to IV according to Cotswolds. The proportion of patients with stages I or II treated with consolidative radiotherapy will be capped at 40%. * Previously treated NLPHL, any stage. * According to the treating physician, the patient should not be observed and needs therapy, notably because of B-symptoms (unexplained fever \[temperature \> 38 degrees Celsius (\> 100.4 degrees Fahrenheit)\], weight loss \[unexplained loss of \> 10 percent of body weight over the past six months\], or drenching night sweats), symptomatic nodal or extranodal disease, or patient preferences. * Patients must have measurable disease according to the Lugano/Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) classification. * Age \>= 18 years. Because no dosing or adverse event (AE) data are currently available on the use of mosunetuzumab in patients \< 18 years of age, children are excluded from this study. * Eastern Cooperative Oncology Group performance status =\< 2 (Karnofsky \>= 60%). * Absolute neutrophil count \>= 1,000/mcL. * Platelets \>= 100,000/mcL. * Total bilirubin =\< 1.5 institutional upper limit of normal (ULN), except in patients with Gilbert's syndrome as defined by \> 80% unconjugated bilirubin. * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT)(serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN. * Glomerular filtration rate (GFR) \>= 40mL /min= GFR (mL/Min/1.73 m\^2) \* body surface area (BSA)/1.73. * Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * 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. * The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal and/or barrier method of birth control; abstinence) (both hormonal and barrier method of birth control are required for participants in Canada) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of mosunetuzumab administration and 12 months after completion of rituximab administration. * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * Classical Hodgkin lymphoma (cHL) or composite lymphoma. * Active transformed NLPHL, concerns of the treating physician of an active occult transformation or concerns of the treating physician that the patient needs cytotoxic therapy. Participants with a history of transformed NLPHL in complete remission for at least 2 years since completion of cytotoxic therapy are eligible * NLPHL relapse less than 6 months after rituximab or rituximab-containing therapy. * Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia. * Patients who are receiving any other investigational agents. * Patients with central nervous system (CNS) involvement as a result of lymphoma. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or rituximab. * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous. * Pregnant women are excluded from this study because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with mosunetuzumab; breastfeeding should be discontinued if the mother is treated with mosunetuzumab or rituximab. These potential risks may also apply to other agents used in this study. * Prior allogeneic stem cell or solid organ transplantation. * Participants who have received a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live, attenuated vaccine will be required during the study. Participants must not receive live, attenuated vaccines (e.g., FluMist \[registered trademark\]) while receiving study treatment and after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity. * Any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment. * Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results as judged by the investigator, including, but not limited to: * Significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina). * Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm). * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. * Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. * Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible only for the expansion cohort. * History of confirmed progressive multifocal leukoencephalopathy (PML). * Participants with infections requiring IV treatment with antibiotics or hospitalization (grade 3 or 4) within the last 4 weeks prior to enrollment or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment. * Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to first dose of study treatment. * Known or suspected chronic active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection. * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
35 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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City of Hope Comprehensive Cancer Center
RECRUITINGDuarte, California, 91010, United States
Contact Email: •••••@•••••
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Emory University Hospital/Winship Cancer Institute
ACTIVE_NOT_RECRUITINGAtlanta, Georgia, 30322, United States
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Huntsman Cancer Institute/University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
Contact Email: •••••@•••••
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITINGAventura, Florida, 33180, United States
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UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITINGCoral Gables, Florida, 33146, United States
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UM Sylvester Comprehensive Cancer Center at Coral Springs
RECRUITINGCoral Springs, Florida, 33065, United States
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITINGDeerfield Beach, Florida, 33442, United States
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UM Sylvester Comprehensive Cancer Center at Doral
RECRUITINGDoral, Florida, 33166, United States
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UM Sylvester Comprehensive Cancer Center at Hollywood
RECRUITINGHollywood, Florida, 33021, United States
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UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITINGMiami, Florida, 33176, United States
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UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITINGPlantation, Florida, 33324, United States
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UPMC Hillman Cancer Center
ACTIVE_NOT_RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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UT MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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University Health Network-Princess Margaret Hospital
RECRUITINGToronto, Ontario, M5G 2M9, Canada
Contact Email: •••••@•••••
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University of Cincinnati Cancer Center-UC Medical Center
RECRUITINGCincinnati, Ohio, 45219, United States
Contact Email: •••••@•••••
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University of Cincinnati Cancer Center-West Chester
RECRUITINGWest Chester, Ohio, 45069, United States
Contact Email: •••••@•••••
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University of Kansas Cancer Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Cancer Center - Briarcliff
RECRUITINGKansas City, Missouri, 64116, United States
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University of Kansas Cancer Center - Lee's Summit
RECRUITINGLee's Summit, Missouri, 64064, United States
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University of Kansas Cancer Center - North
RECRUITINGKansas City, Missouri, 64154, United States
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University of Kansas Cancer Center at North Kansas City Hospital
SUSPENDEDNorth Kansas City, Missouri, 64116, United States
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University of Kansas Cancer Center-Overland Park
RECRUITINGOverland Park, Kansas, 66210, United States
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University of Kansas Hospital-Westwood Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
RECRUITINGNorth Miami, Florida, 33181, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Virginia Cancer Center
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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VCU Massey Comprehensive Cancer Center
RECRUITINGRichmond, Virginia, 23298, United States
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Wake Forest University Health Sciences
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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