A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

Recruiting now · Phase 3

Conditions studied: Lymphoma

In brief

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Key facts

Study ID: NCT06084936
Run by: Hoffmann-La Roche
People needed: 182
Starts: 2023-10-22
Expected to finish: 2028-03-31
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Ictrials Pesquisa e Desenvolvimento — Curitiba, Paraná, Brazil (enrolling)
Valkyrie Clinical Trials — Los Angeles, California, United States (enrolling)
Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
Epworth Hospital — Richmond, Victoria, Australia (enrolling)
Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
University of Miami — Coral Gables, Florida, United States (enrolling)
Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
City of Hope Cancer Center — Duarte, California, United States (enrolling)
Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
University of Iowa Health Care — Waukee, Iowa, United States (enrolling)
University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
St. Luke's Hospital — Chesterfield, Missouri, United States (enrolling)
Renown Regional Medical Center — Reno, Nevada, United States (enrolling)
Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
Hematology Oncology Associates of Central New York — East Syracuse, New York, United States (enrolling)
University of Rochester — Rochester, New York, United States (enrolling)
Stony Brook University Hospital Cancer Center — Stony Brook, New York, United States (enrolling)
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica — Santa Monica, California, United States (enrolling)
University of Iowa — Iowa City, Iowa, United States (enrolling)
Renovatio Clinical - El Paso — El Paso, Texas, United States (enrolling)
Renovatio Clinical — The Woodlands, Texas, United States (enrolling)
University of Virginia — Charlottesville, Virginia, United States (enrolling)
West Virginia University — Morgantown, West Virginia, United States (enrolling)
Calvary Mater Newcastle — Waratah, New South Wales, Australia (enrolling)
Hospital Mae de Deus — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)

Full record on ClinicalTrials.gov

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