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Recruiting Phase 1 NCT06342986

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

Trial Parameters

Condition Gynecologic Cancer
Sponsor Masonic Cancer Center, University of Minnesota
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 33
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-07-11
Completion 2026-12-31
Interventions
FT536FludarabineCY

Brief 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 Criteria

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 yea

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