drugset / Trial / NCT04630769
FT516 and IL2 With Enoblituzumab for Ovarian Cancer
Phase 1
Completed
3 enrolled
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a single center Phase I clinical trial of FT516 administered intraperitoneally (IP) once a week for 3 consecutive weeks for the treatment of recurrent gynecologic cancers. As this is an early 1st in human study and the 1st intraperitoneal infusion of FT516, the safety of FT516 is confirmed prior to adding enoblituzumab as an intravenous infusion approximately 1 week prior to the 1st dose of FT516 and every 3 weeks beginning on Day 22 (1 week after the last dose of FT516). Each dose of FT516 is followed directly by an IP infusion of interleukin-2 (IL-2) to facilitate natural killer (NK) cell survival. A short course of outpatient lymphodepletion chemotherapy is given prior to the 1st dose of FT516.
Timeline
- Start
- 2021-04-02
- Primary completion
- 2022-01-01
- Completion
- 2022-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoblituzumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | FT516 | Cell therapy | 9e+07 cells | Other |
| Subject | FT516 | Cell therapy | 3e+08 cells | Other |
| Subject | FT516 | Cell therapy | 9e+08 cells | Other |
| Background | aldesleukin | Protein / enzyme biologic | 3e+06 unknown | Other |
| Background | aldesleukin | Protein / enzyme biologic | 6e+06 iu | Other |