Actively Recruiting
Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-05
10
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
A
Anixa Biosciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this first in human study is to evaluate the safety of treatment with autologous T cells genetically modified to express a CER (chimeric endocrine receptor) targeting the FSHR (follicle-stimulating hormone receptor) (FSHCER T cells), with or without conditioning chemotherapy, in participants with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer.
CONDITIONS
Official Title
Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older and able to provide informed consent.
- Diagnosed with invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer including serous, endometrioid, clear cell, mucinous, mixed epithelial, undifferentiated, borderline serous ovarian tumors, or sex cord-stromal tumors.
- Have measurable or detectable disease.
- Consent to tumor sample collection for research.
- Have had at least one prior platinum-based chemotherapy and at least two prior chemotherapy regimens.
- Considered platinum-refractory or resistant and unlikely to benefit from standard therapies.
- Patients with BRCA mutations should have received a PARP inhibitor if appropriate.
- For Granulosa Cell Tumors, prior hormonal therapy such as letrozole is required.
- For Borderline Ovarian Tumors, consideration of MEK inhibitor treatment should be documented.
- For high-grade serous cancers, consideration of Folate Receptor-alpha antibody drug conjugate should be documented if eligible.
- Allowed up to 8 prior chemotherapy regimens including platinum-based treatments.
- Prior hormonal therapy must be stopped at least one week before T-cell infusion; hormone replacement therapy may continue.
- Allowed biologic or targeted therapies as part of prior treatments.
- ECOG performance status of 2 or better or Karnofsky score ≥60%.
- Life expectancy of at least 3 months.
- Adequate bone marrow, kidney, and liver function.
- No anticancer therapy in the 3 weeks before T-cell infusion with resolved hematologic effects.
- No prior checkpoint blockade immunotherapy in 3 months before infusion with resolved side effects.
- Agree to placement of peritoneal port and central line catheter.
- Agree to contraception if of childbearing potential from screening until 6 months after infusion.
You will not qualify if you...
- Active hepatitis B infection, or history of hepatitis C or HIV infection.
- Evidence of bowel obstruction or need for parenteral nutrition.
- Extensive abdominal adhesions preventing port placement or infusion.
- Significant heart disease including class 3 or 4 heart failure or recent myocardial infarction within 6 months.
- History of serious arrhythmia or unexplained syncope not due to dehydration.
- Severe non-ischemic cardiomyopathy with ejection fraction below 20%.
- ECG or ECHO findings requiring intervention before cancer therapy.
- Active autoimmune diseases except stable autoimmune thyroid disease.
- Known or suspected leptomeningeal disease or brain metastases in critical brain areas.
- Untreated brain metastases; stable, previously treated lesions are allowed under conditions.
- History of significant seizure disorder.
- Other active cancers requiring treatment besides observation.
- Prior radiotherapy to abdomen or pelvis.
- Currently pregnant or breastfeeding.
- Serious uncontrolled illness, active uncontrolled infection, abdominal fistula, gastrointestinal perforation, or abscess within 28 days before treatment.
- Abdominal surgery other than port placement within 28 days before treatment.
- Any other condition deemed ineligible by the treating physician or investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
A
Ashley K O'Neil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here