Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
NCT06342986 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2026-04-02
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.
Conditions
- Gynecologic Cancer
- Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cavity Cancer
Interventions
- DRUG
-
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line.
- DRUG
-
Fludarabine 25 mg/m2 IV given on day -5. Given consecutively with CY.
- DRUG
-
CY
CY 300 mg/m2 IV given on day -4. Given consecutively with Fludarabine.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Masonic Cancer Center, University of Minnesota
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-11
- Primary Completion
- 2026-03-26
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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