FT536 for Gynecologic Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called FT536 for women with recurring gynecologic cancers, such as ovarian cancer. FT536 is a type of cell therapy that uses modified natural killer cells to target cancer cells. Participants will receive this treatment three times over a week, following a short course of chemotherapy to enhance its effectiveness. This trial may suit those who have previously tried treatments like bevacizumab and, if they have a BRCA mutation, a PARP inhibitor, but are still seeking options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot be on systemic immunosuppressive therapy or have had recent chemotherapy, biological therapy, or radiation therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that FT536 is likely to be safe for humans?
Research shows that treatments using natural killer (NK) cells, such as FT536, are generally safe for humans. Studies have found that donor-derived NK cells are safe and well-tolerated in treating ovarian cancer. These treatments target cancer cells while sparing healthy ones. Early trials have not reported serious side effects, indicating promise in terms of safety. As FT536 remains in early testing, safety is under close observation, but past research on similar treatments suggests it is likely safe.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for gynecologic cancers, which often include surgery, chemotherapy, and radiation, FT536 offers a novel approach through immunotherapy. FT536 is unique because it uses engineered natural killer (NK) cells derived from human induced pluripotent stem cells (iPSCs). These cells are enhanced with a chimeric antigen receptor (CAR) targeting MICA/B proteins and have a CD38 knockout, which helps them better identify and destroy cancer cells. Additionally, FT536 is equipped with a high-affinity, non-cleavable CD16 receptor and an IL-15/IL-15 receptor alpha fusion protein, boosting the immune response. Researchers are excited because this treatment has the potential to be more targeted and effective against cancer cells, reducing damage to healthy cells and possibly leading to better outcomes for patients.
What evidence suggests that FT536 could be an effective treatment for gynecologic cancers?
Research shows that treatments like FT536, which use natural killer (NK) cells, could help treat gynecologic cancers. FT536 involves specially designed NK cells that target and destroy cancer cells. Early studies suggest this method is safe and effective. These NK cells are altered to better identify and attack tumor cells, especially in gynecological cancers. Research indicates that CAR-NK therapies can boost the body's immune response against cancer. While specific data on FT536 is still being gathered, using NK cells in cancer treatment has shown promising results in similar cases. Strong scientific evidence suggests FT536 could effectively treat these recurring cancers. Participants in this trial will receive different doses of FT536 to evaluate its safety and effectiveness.12678
Are You a Good Fit for This Trial?
This trial is for individuals with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Participants must have had certain prior treatments, including a PARP inhibitor if they have a BRCA mutation and bevacizumab. They need to agree to an intraperitoneal catheter placement and sign up for long-term follow-up. Adequate organ function is required.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer
Treatment
FT536 administered intraperitoneally 3 times a week for one week
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FT536
FT536 is already approved in United States for the following indications:
- None approved yet; currently in Phase 1 clinical trials for advanced solid tumors including ovarian cancer, fallopian tube cancer, and primary peritoneal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Masonic Cancer Center, University of Minnesota
Lead Sponsor
National Cancer Institute (NCI)
Collaborator