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Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

NCT06342986•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

This is a single center Phase I clinical trial of FT536 administered intraperitoneally (IP) 3 times a week for one week for the treatment of recurrent gynecologic cancers. A short course of outpatient lymphodepleting chemotherapy is given prior to the first dose of FT536 to promote adoptive transfer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments).
•Must have received prior bevacizumab.
•In the presence of a BRCA mutation, must have received a prior PARP inhibitor.
•Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu) start
•Agrees to the placement of an intraperitoneal catheter before the 1st dose of study directed drug (chemotherapy) and remains in place through Day 36 or longer if retreatment is planned. Refer to Section 6.4 if catheter cannot be successfully placed.
•Agrees to undergo a tumor biopsy if feasible at the time the catheter is placed and removed - Accessible tumor for biopsy is not required for eligibility
•Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077) to fulfill the FDA recommended 15 years of followup for a genetically modified cell product.

Exclusion Criteria

•Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months. If of childbearing potential (have a uterus and ovaries) and engaged in heterosexual intercourse, must have a negative pregnancy test (serum or urine) within 14 days before the 1st CY/Flu. Patient must agree to use highly effective method of birth control from the screening visit until at least 12 months after the final dose of CY, or at least 4 months after the final dose of FT536, whichever is longer.
•Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone \>5 mg daily) for any reason from Day -5 to 14 days after the last FT536 infusion) with the exception of corticosteroids as a pre-medication per institutional standard of care - topical and inhaled steroids are permitted.
•Active autoimmune disease requiring systemic immunosuppressive therapy.
•History of severe asthma and currently on chronic systemic medications.
•Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy.
•Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT536 or five half-lives, whichever is shorter; or any investigational agent within 28 days prior to the first dose of FT536.
•Live vaccine within 6 weeks prior to start of lympho-conditioning.
•Known allergy to the following FT536 components: albumin (human) or dimethyl sulfoxide (DMSO).
•Prior enoblituzumab.
•Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.)
+3 more criteria

Locations (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Key Dates

Start Date

July 11, 2024

Primary Completion Date

December 31, 2026

Completion Date

June 30, 2027

Last Updated

November 12, 2025

Enrollment

ESTIMATED participants

Conditions

Gynecologic CancerOvarian CancerFallopian Tube CancerPrimary Peritoneal Cavity Cancer

Interventions

FT536

DRUG

Fludarabine

DRUG

Contacts

Melissa Geller, MD

CONTACT

612-626-3111 gelle005@umn.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Inclusion Criteria

Exclusion Criteria

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