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.

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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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.

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

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.

0 / 6Eligibility 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.