Recruiting
Phase 3

Glofitamab vs. Investigator's Choice

Sponsor:

Hoffmann-La Roche

Code:

NCT06084936

Conditions

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Obinutuzumab

Glofitamab

Rituximab

Bendamustine

Lenalidomide

Study Details

Brief summary:

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).

Conditions

Lymphoma

Study ID

NCT06084936

Start date

Oct 22, 2023

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glofitamab monotherapy

Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).

active comparator: BR or R-Len

Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.

Interventions

Obinutuzumab

Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1

Glofitamab

Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).

Rituximab

Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).

Bendamustine

Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).

Lenalidomide

Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.

Tocilizumab

Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause (up to approximately 24 months) ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below.

888-662-6728global-roche-genentech-trials@gene.com

Locations

City of Hope Cancer Center

Recruiting

Duarte, California, United States, 91010

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

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

Recruiting

Santa Monica, California, United States, 90404-2023

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Georgetown University

Recruiting

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

University of Miami

Recruiting

Coral Gables, Florida, United States, 33146

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

University of Iowa Health Care

Recruiting

Waukee, Iowa, United States, 50263

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

St. Luke's Hospital

Recruiting

Chesterfield, Missouri, United States, 63017

Renown Regional Medical Center

Recruiting

Reno, Nevada, United States, 89502

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Hematology Oncology Associates of Central New York

Recruiting

East Syracuse, New York, United States, 13057

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Stony Brook University Hospital Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Renovatio Clinical - El Paso

Recruiting

El Paso, Texas, United States, 79915

Renovatio Clinical

Recruiting

The Woodlands, Texas, United States, 77380

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22906

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Victoria Hospital - London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-05.