Trials / Active Not Recruiting
Active Not RecruitingNCT06342986
Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FT536 | FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master humaninduced pluripotent stem cell (iPSC) line. |
| DRUG | Fludarabine | 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. |
Timeline
- Start date
- 2024-07-11
- Primary completion
- 2026-03-26
- Completion
- 2027-06-30
- First posted
- 2024-04-02
- Last updated
- 2026-04-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06342986. Inclusion in this directory is not an endorsement.