What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as chemotherapy, targeted therapy, and immunotherapy, have various side effects. Chemotherapy often causes nausea, vomiting, fatigue, anemia, and increased risk of infection. Targeted therapies, like PARP inhibitors, can lead to anemia, nausea, fatigue, and sometimes more severe effects like myelosuppression. Immunotherapy, including treatments similar to FSHCER T cells, may cause immune-related adverse events such as skin reactions, colitis, pneumonitis, and endocrinopathies. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer have included various chemotherapy agents, targeted therapies, and immunotherapies. Notably, PARP inhibitors like olaparib, niraparib, and rucaparib have been approved for patients with BRCA mutations or other homologous recombination deficiencies. Bevacizumab, an angiogenesis inhibitor, has also been approved for use in combination with chemotherapy. While there are no FDA-approved treatments directly analogous to the genetically modified T cells targeting FSHR being studied in the FSHCER T cells trial, the field of immunotherapy is expanding, with ongoing research into CAR-T cell therapies and other novel approaches for ovarian cancer.

What other types of research exist?

Promising novel alternatives to FSHCER T cells for ovarian cancer patients include: 1) Anti-TSHR CAR-T cells, which have shown significant antitumor activity and safety in preclinical models of differentiated thyroid cancer and could be adapted for ovarian cancer. 2) E39+GM-CSF vaccine targeting folate binding protein, which is in phase I/IIa trials for preventing recurrence in ovarian and endometrial cancer patients. 3) Pembrolizumab, an anti-PD-1 monoclonal antibody, which has demonstrated efficacy in advanced programmed death ligand 1-positive ovarian cancer. 4) Tisotumab vedotin, an antibody-drug conjugate, which has shown efficacy in previously treated recurrent or metastatic cervical cancer and may be applicable to ovarian cancer.

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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 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.

No prior immunotherapy with checkpoint blockade in the 6 months before the T-cell infusion.

Must not have

Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess.

Abdominal surgery (for reasons other than IP port placement).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new treatment that uses a patient's own modified immune cells to target and kill cancer cells. It focuses on patients whose ovarian, fallopian tube, or primary peritoneal cancer has come back or hasn't responded to other treatments.

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.

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.

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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I have had 1 platinum-based and at least 2 other chemotherapy treatments for ovarian, peritoneal, or fallopian tube cancer.

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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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My cancer can be measured or detected by tests.

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My cancer tests positive for the FSHR antigen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had issues like an abdominal fistula, gut perforation, or abscess.

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I have had abdominal surgery not related to IP port placement.

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I have signs of a blocked intestine or need IV fluids or feeding.

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I might have untreated cancer spread to my brain.

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I haven't had a heart attack or serious heart rhythm problems in the last 6 months.

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I do not have severe heart disease or symptoms of heart failure.

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I have a history of serious seizures.

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I have had radiation therapy to my abdomen or pelvis.

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I have an active hepatitis B, or a history of hepatitis C or HIV.

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I have cancer spread to the brain or its coverings.

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I have a severe heart condition with very low heart pump efficiency.

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I am not currently receiving treatment for any other cancer besides the one being studied.

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I do not have extensive abdominal adhesions that would prevent surgery.

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I have an autoimmune disease, but it's not thyroid-related or my thyroid condition is stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose of FSHCER T Cells

Secondary study objectives

Duration of Response

Duration of Stable Disease

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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.

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include platinum-based chemotherapy, PARP inhibitors, and investigational therapies like genetically modified T cells targeting FSHR. Platinum-based chemotherapy works by causing DNA damage that cancer cells cannot repair, leading to cell death. PARP inhibitors prevent cancer cells from repairing DNA damage, particularly effective in cancers with BRCA mutations or homologous recombination deficiencies. Genetically modified T cells, such as FSHCER T cells, are designed to target specific receptors on cancer cells, enhancing the immune system's ability to recognize and destroy these cells. These treatments are crucial as they offer targeted approaches to combat ovarian cancer, potentially improving survival rates and reducing recurrence.