RecruitingPhase 1NCT06342986

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


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

33 participants

Start Date

Jul 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental cell therapy (FT536, a type of NK cell therapy) delivered directly into the abdomen in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer — cancers that keep coming back after prior treatments. **You may be eligible if...** - You have recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer - You have previously received bevacizumab as part of your treatment - If your tumor has a BRCA mutation, you have previously received a PARP inhibitor - You are willing to have an intraperitoneal catheter (a tube in your abdomen) placed for the treatment - Your organ function is adequate **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning pregnancy in the next 6 months - You are unable to have the catheter placed safely - You are unwilling to participate in the required long-term follow-up study (up to 15 years) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFT536

FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.

DRUGFludarabine

Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.

DRUGCY

CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.


Locations(1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

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NCT06342986


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