FSHR-Targeted T Cell Therapy for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for ovarian, fallopian tube, or primary peritoneal cancer using genetically modified T cells targeting the follicle-stimulating hormone receptor (FSHR-Targeted T Cell Therapy). The trial aims to determine the safety of the treatment when administered alone or with chemotherapy. Participants will receive varying doses of the treatment either intravenously or directly into the abdomen. The trial seeks individuals with recurrent or persistent cancer after previous treatments, for whom standard therapies are unlikely to be effective. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you must stop all current medications. However, hormonal therapy must be stopped at least 1 week before T-cell infusion, and no anticancer therapy is allowed in the 3 weeks before the T-cell infusion. Continuation of hormone replacement therapy is permitted.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop all current medications, but hormonal therapy must be stopped at least 1 week before the T-cell infusion. You should also not have any anticancer therapy in the 3 weeks before the T-cell infusion.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that new treatments are being tested for safety in women with ovarian cancer. These treatments target the follicle-stimulating hormone receptor (FSHR) and use modified T cells, a type of immune cell, to locate and attack cancer cells.
Studies have found that patients generally tolerate this therapy well. Common side effects may include mild flu-like symptoms, typical for similar treatments. More serious side effects have not been widely reported, but researchers continue to monitor safety.
As this is an early-phase trial, the main goal is to assess the treatment's safety and patient tolerance. Researchers closely monitor participants for any side effects. Although this treatment is new, the careful approach aims to ensure safety for those involved.12345Why are researchers excited about this trial's treatment?
Unlike the standard treatments for ovarian cancer, which often involve chemotherapy or surgery, FSHR-targeted T cell therapy takes a novel approach by aiming directly at the follicle-stimulating hormone receptor (FSHR) found on ovarian cancer cells. This therapy uses engineered T cells, which are a type of immune cell, to specifically recognize and attack cancer cells, potentially sparing more healthy cells compared to traditional methods. Researchers are excited about this because it could lead to more precise and less toxic cancer treatment options. Additionally, the trial explores different administration routes and doses, like intravenous and intraperitoneal infusions, which could optimize how effectively the T cells reach the cancerous areas.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Studies have shown that specially designed T cells targeting the follicle-stimulating hormone receptor (FSHR) can effectively combat ovarian cancer. These T cells are modified to locate and attack cancer cells with FSHR. Research indicates this method is promising because FSHR primarily appears on ovarian cancer cells, enabling a focused attack. Previous findings suggest this approach is both safe and effective in shrinking tumors. In this trial, participants will receive varying doses and routes of administration of these engineered T cells, known as Follicle-Stimulating Hormone Receptor T (FSHCER T) cells. Early clinical trials reported positive results for safety and effectiveness in treating recurring ovarian cancer with these engineered T cells.25678
Who Is on the Research Team?
Robert M Wenham, MD, MS, FACOG, FACS
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with recurrent ovarian, fallopian tube, or primary peritoneal cancer who've had at least one platinum-based and two other chemotherapy treatments. They must have a life expectancy of over 3 months, no recent anticancer therapy or immunotherapy, and agree to use contraception. The cancer must express FSHR antigen.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one infusion of FSHCER T cells at various dose levels, administered either intravenously or intraperitoneally
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Follicle Stimulating Hormone Receptor T Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Anixa Biosciences, Inc.
Collaborator