General Information |
| 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. |
| 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. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2021-04-02 |
| End date (estimated) |
2022-01-01 |
| Clinical feature |
| Label |
ovarian cancer |
| Link |
http://purl.obolibrary.org/obo/DOID_2394 |
| Description |
A female reproductive organ cancer that is located_in the ovary.; Xref MGI.
OMIM mapping confirmed by DO. [SN]. |
|
Administrative Information |
| NCT number |
NCT04630769 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=TrialID=NCT04630769 |
| IND number |
19674 |
| Other study identifiers |
| Name |
P01CA111412 |
| Description |
(U.S. NIH Grant/Contract) |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04630769 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
ccinfo@umn.edu |
| Public email |
ccinfo@umn.educcinfo@umn.edu |
| Last name |
Cancer Center Clinical Trials Office |
| Phone |
+1 612 676-4200 |
| City |
Minnesota |
| Country |
|
| Address freetext |
University of Minnesota, Masonic Cancer Center Minneapolis, Minnesota, United States, 55455 |
|
| Sponsors |
Masonic Cancer Center, University of Minnesota
|
| Collaborators |
|
Cells |
| Which differentiated cell type is used |
| Label |
natural killer cell |
| Link |
http://purl.obolibrary.org/obo/CL_0000623 |
| Description |
A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells. |
|
Recruitment |
| Recruitment Status |
Completed |
| Estimated number of participants |
3 |
