A Multicenter Phase 2 Study of Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
University of California, San Francisco
Summary
This phase II trial tests the safety and effectiveness of glofitamab given in combination with pirtobrutinib 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). Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Obinutuzumab may also reduce the risk of immune-related conditions from treatment. Pirtobrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the protein that signals cancer cells to multiply. Giving glofitamab in combination with pirtobrutinib may be safe, tolerable and/or effective in treating patients with relapsed or refractory mantle cell lymphoma.
Description
PRIMARY OBJECTIVES: I. To characterize the safety and tolerability of the combination of glofitamab and pirtobrutinib in the first six participants enrolled. II. To evaluate the preliminary efficacy of glofitamab and pirtobrutinib in participants with relapsed or refractory mantle cell lymphoma (MCL) as measured by complete response rate. SECONDARY OBJECTIVES: I. To evaluate the preliminary efficacy of glofitamab and pirtobrutinib in participants with relapsed or refractory MCL as measured by progression-free survival and overall survival. II. To characterize the magnitude and duration of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years at the time of signing the informed consent form. * Have a life expectancy (in the opinion of the investigator) of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Karnofsky \> 60%). * History of previously treated MCL meeting the following criteria: Relapsed after or failed to respond to at least one prior line of systemic therapy including anti-CD20 monoclonal antibody and alkylator-containing chemotherapy. * At least one bi-dimensionally measurable nodal lesion ( \> 1.5 cm in its largest dimension by PET/CT scan),…
Interventions
- BiologicalObinutuzumab
Given intravenously (IV)
- BiologicalGlofitamab
Given IV
- DrugPirtobrutinib
Given Orally (PO)
- ProcedureTumor Imaging
Undergo regular care imaging/scans
- ProcedureBiospecimen Collection
Blood and tissue samples
- DeviceClonoSeq Assay
ClonoSEQ is an FDA-cleared, Clinical Laboratory Improvement Amendments of 1988 (CLIA)-validated measure used to determine minimal residual disease (MRD). This helps uncover how much, if any, cancer remains in your body during and after treatment.
- Procedure
Locations (3)
- University of California, DavisDavis, California
- University of California, Los AngelesLos Angeles, California
- University of California, San FranciscoSan Francisco, California