A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy
National Cancer Institute (NCI)
Summary
This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.
Description
PRIMARY OBJECTIVE: I. To determine the proportion of relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients with an objective response (OR) to glofitamab after prior treatment with chimeric antigen receptor (CAR)-T. SECONDARY OBJECTIVES: I. To describe the proportion of patients with a complete response (CR). II. To describe the progression-free survival (PFS) and overall survival (OS) at 24 months. III. To describe the incidence of grade 3-4 cytokine release syndrome (CRS). IV. To describe the incidence of grade 3-4 neurologic toxicity. V. To describe the relationship between glofi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed diagnosis of mantle cell lymphoma that is relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) * Patients must have been previously treated with an anti-CD19 CAR T-cell therapy and have failed or been intolerant to Bruton's tyrosine kinase (BTK) inhibition. Both commercial and investigational CAR-T products which target CD19 will be allowed, including dual-targeting products * Patients must have at least…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo PET/CT
- BiologicalGlofitamab
Given IV
- BiologicalObinutuzumab
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
Locations (5)
- City of Hope Comprehensive Cancer CenterDuarte, California
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia
- Emory Saint Joseph's HospitalAtlanta, Georgia
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee