Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Davis, California.

Sponsor
University of California, San Francisco
Study ID
NCT06252675
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — BIOLOGICAL
    Given intravenously (IV)
  • Glofitamab — BIOLOGICAL
    Given IV
  • Pirtobrutinib — DRUG
    Given Orally (PO)
  • Tumor Imaging — PROCEDURE
    Undergo regular care imaging/scans
  • Biospecimen Collection — PROCEDURE
    Blood and tissue samples
  • ClonoSeq Assay — DEVICE
    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.
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration.

Study Details

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.

Key Dates

Start date
Jun 11, 2024
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (obinutuzumab, glofitamab, pirtobrutinib)
    Participants receive obinutuzumab IV on days 1 and 2 of cycle 1 for a total of 2 doses. Participants receive glofitamab IV on days 8 and 15 of cycle 1 and day 1 of remaining cycles. Cycles repeat every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Participants receive pirtobrutinib PO once a day (QD) on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity up to Cycle 30, Day 22. Participants also undergo FDG-PET/CT at screening, after every 4 cycles through cycle 13 and then after every 6 cycles. Participants will undergo a bone marrow biopsy and aspiration at cycle 13 and blood sample collection throughout study and a tissue biopsy at relapse or progression.

Primary Outcome Measure

Percentage of participants with high grade, treatment-emergent adverse events (AEs) [ Time Frame: Approximately 2 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, DavisDavisCalifornia95616
Hildy Donner
[email protected]
Leigh Ann Morris
[email protected]
University of California, Los AngelesLos AngelesCalifornia90095
Steven Singer
[email protected]
Patricia Young, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
[email protected]
[email protected]
Madhav Seshadri, MD (PRINCIPAL_INVESTIGATOR)
C. Babis Andreadis, MD (SUB_INVESTIGATOR)

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By research site
University of California, Davis· Davis, CAUniversity of California, Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CA

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