Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. 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). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.
Eligibility criteria
Qualifiers
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Disqualifiers
Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Prior solid organ transplantation
Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anti cytotoxic T lymphocyte associated protein 4, anti PD-1, and anti PD-L1) within 2 weeks or five half-lives of the drug, whichever is shorter, prior to day 1 of protocol therapy
Prior treatment with glofitamab or other CD20 x CD3 bispecific antibodies
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Computed Tomography
- Glofitamab
- Lumbar Puncture
- Magnetic Resonance Imaging
- Obinutuzumab
- Positron Emission Tomography
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov