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CAR T-cell Therapy

FSHR-Targeted T Cell Therapy for Ovarian Cancer

Phase 1
Recruiting
Led By Robert M Wenham, MD, MS, FACOG, FACS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients should be considered platinum-refractory or resistant and be deemed unlikely to have significant benefit from any standard therapies by the treating investigator.
Patients must have had 1 prior platinum-based chemotherapeutic regimen for the management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least 2 prior chemotherapy regimens.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

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.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the safety of genetically modified T cells targeting the FSH receptor in patients with certain types of ovarian cancers. It explores treatment effectiveness both with and without additional chemotherapy.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to genetic modification of T cells, typical chemotherapy-related issues like nausea and fatigue if used alongside chemo, as well as site-specific complications from port placement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not respond well to platinum-based treatments.
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I have had 1 platinum-based and at least 2 other chemotherapy treatments for ovarian, peritoneal, or fallopian tube cancer.
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My kidney, liver, and bone marrow are working well.
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I have a confirmed high-grade cancer of the ovary, peritoneum, or fallopian tube.
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I may or may not be on targeted cancer therapy.
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I haven't had any cancer treatments like chemotherapy or immunotherapy in the last 3 weeks.
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I haven't had immunotherapy with checkpoint inhibitors in the last 6 months.
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I agree to have a port placed in my abdomen for treatment.
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I can take care of myself but cannot do any physical work.
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I have a BRCA mutation and have either tried a PARP inhibitor and it didn't work, or I can't take oral medications.
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I may have had up to 6 chemotherapy treatments, including ones with platinum.
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My cancer can be measured or detected by tests.
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My cancer tests positive for the FSHR antigen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose of FSHCER T Cells
Secondary outcome measures
Duration of Response
Duration of Stable Disease
Overall Survival

Trial Design

10Treatment groups
Experimental Treatment
Group I: Intravenous treatment - Dose Level 5Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7 by Intravenous (IV).
Group II: Intravenous treatment - Dose Level 4Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6 by Intravenous (IV).
Group III: Intravenous treatment - Dose Level 3Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6 by Intravenous (IV).
Group IV: Intravenous treatment - Dose Level 2Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5 by Intravenous (IV).
Group V: Intravenous treatment - Dose Level 1Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5 by Intravenous (IV).
Group VI: Intraperitoneal treatment- Dose Level 5Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^7. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
Group VII: Intraperitoneal treatment- Dose Level 4Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
Group VIII: Intraperitoneal treatment- Dose Level 3Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^6. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
Group IX: Intraperitoneal treatment- Dose Level 2Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 3 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.
Group X: Intraperitoneal treatment- Dose Level 1Experimental Treatment1 Intervention
Participants will receive one infusion of Follicle-Stimulating Hormone Receptor T (FSHCER T) cells at a dose of 1 x 10^5. Intraperitoneal: Infusion will be administered through a thin membrane of the abdominal cavity.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
540 Previous Clinical Trials
135,387 Total Patients Enrolled
10 Trials studying Ovarian Cancer
569 Patients Enrolled for Ovarian Cancer
Anixa Biosciences, Inc.UNKNOWN
1 Previous Clinical Trials
45 Total Patients Enrolled
Robert M Wenham, MD, MS, FACOG, FACSPrincipal InvestigatorMoffitt Cancer Center

Media Library

Follicle Stimulating Hormone Receptor T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05316129 — Phase 1
Ovarian Cancer Research Study Groups: Intravenous treatment - Dose Level 2, Intravenous treatment - Dose Level 3, Intraperitoneal treatment- Dose Level 4, Intravenous treatment - Dose Level 4, Intraperitoneal treatment- Dose Level 5, Intravenous treatment - Dose Level 5, Intraperitoneal treatment- Dose Level 3, Intraperitoneal treatment- Dose Level 1, Intravenous treatment - Dose Level 1, Intraperitoneal treatment- Dose Level 2
Ovarian Cancer Clinical Trial 2023: Follicle Stimulating Hormone Receptor T Cells Highlights & Side Effects. Trial Name: NCT05316129 — Phase 1
Follicle Stimulating Hormone Receptor T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05316129 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~16 spots leftby Mar 2025