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FSHR-Targeted T Cell Therapy for Ovarian Cancer
Study Summary
This trial will study if it is safe to use T cells that have been genetically modified to attack the FSHR protein in people with ovarian cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had issues like an abdominal fistula, gut perforation, or abscess.My cancer did not respond well to platinum-based treatments.I do not have any serious infections, except for a simple UTI.I have had 1 platinum-based and at least 2 other chemotherapy treatments for ovarian, peritoneal, or fallopian tube cancer.My kidney, liver, and bone marrow are working well.I have a confirmed high-grade cancer of the ovary, peritoneum, or fallopian tube.I may or may not be on targeted cancer therapy.I haven't had any cancer treatments like chemotherapy or immunotherapy in the last 3 weeks.I haven't had immunotherapy with checkpoint inhibitors in the last 6 months.I agree to have a port placed in my abdomen for treatment.I have signs of a blocked intestine or need IV fluids or feeding.I might have untreated cancer spread to my brain.I have had abdominal surgery not related to IP port placement.I haven't had a heart attack or serious heart rhythm problems in the last 6 months.I do not have severe heart disease or symptoms of heart failure.I can take care of myself but cannot do any physical work.I have a BRCA mutation and have either tried a PARP inhibitor and it didn't work, or I can't take oral medications.I have a history of serious seizures.I may have had up to 6 chemotherapy treatments, including ones with platinum.I have had radiation therapy to my abdomen or pelvis.I have an active hepatitis B, or a history of hepatitis C or HIV.I have cancer spread to the brain or its coverings.My cancer can be measured or detected by tests.I do not have any severe illnesses that my doctor thinks would make me ineligible for the study.I have a severe heart condition with very low heart pump efficiency.I am not currently receiving treatment for any other cancer besides the one being studied.My cancer tests positive for the FSHR antigen.I do not have extensive abdominal adhesions that would prevent surgery.I have an autoimmune disease, but it's not thyroid-related or my thyroid condition is stable.
- Group 1: Intravenous treatment - Dose Level 2
- Group 2: Intravenous treatment - Dose Level 3
- Group 3: Intraperitoneal treatment- Dose Level 4
- Group 4: Intravenous treatment - Dose Level 4
- Group 5: Intraperitoneal treatment- Dose Level 5
- Group 6: Intravenous treatment - Dose Level 5
- Group 7: Intraperitoneal treatment- Dose Level 3
- Group 8: Intraperitoneal treatment- Dose Level 1
- Group 9: Intravenous treatment - Dose Level 1
- Group 10: Intraperitoneal treatment- Dose Level 2
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there any risk associated with utilizing Follicle Stimulating Hormone Receptor T Cells in clinical treatments?
"According to our team's evaluation, Follicle Stimulating Hormone Receptor T Cells is rated a 1 on the safety scale because it has only undergone Phase 1 testing with limited data confirming its efficacy and security."
What is the approximate size of this experimental cohort?
"Affirmative. Clinicaltrials.gov confirms that on March 30th 2022, this trial began its search for participants and is thus currently recruiting. Forty-eight individuals are sought from a single medical centre to take part in the study."
Are there still opportunities to participate in this experiment?
"Verified. Clinicaltrials.gov displays that this trial, which originally launched on March 30th 2022, is recruiting participants currently. There are 48 openings at a single medical centre."
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