Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04630769
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2020-11-11
Brief Title:
FT516 and IL2 With Enoblituzumab for Ovarian Cancer
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Intraperitoneal FATE FT516 and Interleukin-2 IL-2 With Intravenous Enoblituzumab in Recurrent Ovarian Fallopian Tube and Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
FT516 is an off the shelf product comprised of allogeneic natural killer NK cells expressing high-affinity non-cleavable CD16 FT516 Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3 which is highly expressed on ovarian cancer Based on data showing that within the ovarian cancer tumor microenvironment surface expression of CD16a on NK cells is diminished the researchers hypothesize that the FT516 cellular product containing a non-cleavable CD16 will bypass the low CD16 expression issue and maximize NK cell cytotoxicity Enoblituzumab is an Fc optimized humanized IgG1 monoclonal antibody that binds to B7-H3 CD276 B7-H3 is an inhibitory immune checkpoint molecule that is widely expressed by a number of different tumor types and may play a key role in regulating the immune response It is therefore hypothesized that the combination of FT516 with enoblituzumab will maximize NK cell cytotoxicity in patients with ovarian cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01CA111412 | NIH | None | httpsreporternihgovquickSearchP01CA111412 |