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New hope for tough lymphoma: glofitamab takes on relapsed mantle cell cancer

NCT ID NCT06084936

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 6 times

Summary

This Phase 3 study tests whether the experimental drug glofitamab works better than standard treatments (rituximab plus bendamustine or lenalidomide plus rituximab) for people with mantle cell lymphoma that has returned or not responded to prior therapy. About 182 participants will be randomly assigned to receive glofitamab or one of the standard options. The main goal is to see how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glofitamab
What this could lead to
If successful, glofitamab could offer a new, more effective treatment option for people with mantle cell lymphoma that has stopped responding to other therapies.
What could go wrong
This is an early-stage Phase 3 trial with 182 participants, so results may not apply to everyone. Glofitamab may cause side effects like infusion reactions or infections, and it may not work better than existing treatments.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Life expectancy at least 12 weeks * Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry * Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease * At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option * Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment * At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Negative HIV test at screening * Adequate hematological function Exclusion Criteria: * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer * Leukemic, non-nodal MCL * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products * Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide * Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3 * Prior treatment with CAR-T cell therapy * Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment * Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma * Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease * History of other malignancy that could affect compliance with the protocol or interpretation of results * Significant or extensive cardiovascular disease * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment * Suspected or latent tuberculosis * Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV) * Known or suspected chronic active Epstein-Barr viral infection (EBV) * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Known history of progressive multifocal leukoencephalopathy (PML) * Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better * Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study * Prior solid organ transplantation or allogenic stem cell transplant * Eligibility for stem cell transplantation (SCT) * Active autoimmune disease requiring treatment * Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment * Corticosteroid therapy within 2 weeks prior to first dose of study treatment * Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis * Clinically significant history of cirrhotic liver disease

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Conditions

The condition(s) this trial relates to.

lymphoma mantle cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    68 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Locations

  • A.O. Città della Salute e della Scienza D - Osp. S. Giov. Battista Molinette

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Akademiska sjukhuset, Onkologkliniken

    RECRUITING

    Uppsala, 751 85, Sweden

  • Alta Bates Summit Medical Center

    WITHDRAWN

    Berkeley, California, 94704, United States

  • Americas Medical City

    RECRUITING

    Rio de Janeiro, 22775-001, Brazil

  • Asan Medical Center

    COMPLETED

    Seoul, 05505, South Korea

  • Auxilio Mutuo Cancer Center

    RECRUITING

    San Juan, 00918, Puerto Rico

  • Avera Cancer Institute

    WITHDRAWN

    Sioux Falls, South Dakota, 57105, United States

  • Beijing Tong Ren Hospital, Capital Medical University

    RECRUITING

    Beijing, 100730, China

  • Beneficencia Portuguesa de Sao Paulo

    RECRUITING

    São Paulo, 01321-00, Brazil

  • CHU NANTES - Hôtel Dieu

    RECRUITING

    Nantes, 44093, France

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Chang Gung Medical Foundation - Linkou

    RECRUITING

    Taoyuan, 333, Taiwan

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, 400030, China

  • Christie Hospital Nhs Trust

    RECRUITING

    Manchester, M2O 4BX, United Kingdom

  • Chungnam National University Hospital

    WITHDRAWN

    Daejeon, 35015, South Korea

  • City of Hope Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    RECRUITING

    A Coruña, 15006, Spain

  • Derriford Hospital

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Epworth Hospital

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Fudan University Shanghai Cancer Center

    ACTIVE_NOT_RECRUITING

    Shanghai, 200032, China

  • Fujian Provincial Cancer Hospital

    RECRUITING

    Fuzhou, 350014, China

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Guangxi Cancer Hospital of Guangxi Medical University

    RECRUITING

    Nanning, 530021, China

  • Hematology Oncology Associates of Central New York

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, 450008, China

  • Hopital Claude Huriez

    RECRUITING

    Lille, 59037, France

  • Hopital Necker

    RECRUITING

    Paris, 75743, France

  • Hopital Saint Eloi

    RECRUITING

    Montpellier, 34295, France

  • Hospital A. C. Camargo

    RECRUITING

    São Paulo, São Paulo, 01509-010, Brazil

  • Hospital Alemao Oswaldo Cruz

    RECRUITING

    São Paulo, São Paulo, 01327-001, Brazil

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario J.M Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Mae de Deus

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

  • Hospital Paulistano

    RECRUITING

    São Paulo, São Paulo, 01321-000, Brazil

  • Hospital Sao Rafael - HSR

    WITHDRAWN

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Puerta del Mar

    RECRUITING

    Cadiz, Cadiz, 11009, Spain

  • Humanitas Gavazzeni

    RECRUITING

    Bergamo, Lombardy, 24121, Italy

  • INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

    RECRUITING

    Paris, 75005, France

  • Ictrials Pesquisa e Desenvolvimento

    RECRUITING

    Curitiba, Paraná, 80510-130, Brazil

  • Indiana University

    WITHDRAWN

    Indianapolis, Indiana, 46202, United States

  • Instituto D'Or Pesquisa e Ensino

    RECRUITING

    São Paulo, São Paulo, 04502-001, Brazil

  • Irccs Istituto Europeo Di Oncologia (IEO)

    RECRUITING

    Milan, Lombardy, 20141, Italy

  • Lincolnshire County Hospital

    RECRUITING

    Lincoln, LN2 5QY, United Kingdom

  • Medical University of S. Carolina

    WITHDRAWN

    Charleston, South Carolina, 29425, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NHS Greater Glasgow and Clyde

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • National Taiwan Universtiy Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Oxford Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Policlinico S.Orsola-Malpighi

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Renovatio Clinical

    RECRUITING

    The Woodlands, Texas, 77380, United States

  • Renovatio Clinical - El Paso

    RECRUITING

    El Paso, Texas, 79915, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SC Ematologia, AO SS. Antonio e Biagio e C. Arrigo

    RECRUITING

    Alessandria, Piedmont, 15121, Italy

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    Seoul, 135-710, South Korea

  • Seoul National University Hospital

    COMPLETED

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    ACTIVE_NOT_RECRUITING

    Seoul, 003-722, South Korea

  • Skånes University Hospital, Skånes Department of Onclology

    RECRUITING

    Lund, 221 85, Sweden

  • St. Luke's Hospital

    RECRUITING

    Chesterfield, Missouri, 63017, United States

  • Stony Brook University Hospital Cancer Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Sun yat-sen University Cancer Center

    ACTIVE_NOT_RECRUITING

    Guangzhou, 510060, China

  • The First Affiliated Hospital of China Medical University

    RECRUITING

    Shenyang, 110001, China

  • The First Affiliated Hospital of Wenzhou Medical University

    COMPLETED

    Wenzhou, 325035, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, 450003, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, 130021, China

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • University College London Hospital

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University of California Los Angeles (UCLA) - Cancer Care - Santa Monica

    RECRUITING

    Santa Monica, California, 90404-2023, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Iowa Health Care

    RECRUITING

    Waukee, Iowa, 50263, United States

  • University of Miami

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22906, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Victoria Hospital - London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • West China Hospital of Sichuan University

    ACTIVE_NOT_RECRUITING

    Chengdu, 610041, China

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

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