Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial

This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. 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). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a recep

Trial Details

NCT ID
NCT06357676
Phase
PHASE1 / PHASE2
Sponsor
OHSU Knight Cancer Institute
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Biospecimen Collection
  • Bone Marrow Biopsy
  • Computed Tomography
  • Echocardiography
  • FDG-Positron Emission Tomography
  • Glofitamab
Locations (sample)
  • Portland, Oregon, United States|45.52345,-122.67621

Key Eligibility Criteria

  • Ability to understand the purpose and risks of the study and to provide signed informed consent
  • Pathologically confirmed MCL, with documentation of chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association wi…
  • Age 18-64 with one or more of the following poor risk features defined as:
  • High risk mutational variants including p53 aberrations (mutation\[s\] by next generation sequencing \[NGS\] and/or 17p deletion), KMT2D, NSD2, NOT…

For full eligibility, visit ClinicalTrials.gov.

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