Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Int
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03213964|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : January 30, 2018
This is a Phase I trial to determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of a single infusion of FATE-NK100 via intra-peritoneal catheter in women with recurrent ovarian, fallopian tube or primary peritoneal cancer meeting one of the following minimal prior treatment requirement:
- Platinum resistant: may receive FATE-NK100 as 2nd line (as 1st salvage therapy). Platinum resistant is defined as disease that has responded to initial chemotherapy but demonstrates recurrence within a relatively short period of time (< 6 months) following the completion of treatment.
- Platinum sensitive: may receive FATE-NK100 as 3rd line therapy (as 2nd salvage therapy). Platinum sensitive is defined as the recurrence of active disease in a patient who has achieved a documented response to initial platinum-based treatment and has been off therapy for an extended period of time (≥ 6 months).
|Condition or disease||Intervention/treatment||Phase|
|Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer||Biological: FATE-NK100 Drug: Interleukin-2||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraperitoneal Delivery of Adaptive Natural Killer (NK) Cells (FATE-NK100) With Intraperitoneal Interleukin-2 in Women With Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer|
|Actual Study Start Date :||October 19, 2017|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||April 1, 2020|
Experimental: Arm 1
FATE-NK100 is a donor-derived NK cell product comprising ex vivo activated effector cells with enhanced anti-tumor activity.
FATE-NK100 is administered to determine the maximum tolerated doze/maximum feasible dose (MTD/MFD).
Interleukin-2 (IL-2) remains the only FDA approved drug that is capable of promoting NK cells activation and survival.
Lymphodepletion with Cyclophosphamide and Fludarabine.
FATE-NK100 Infusion (Day 0)
The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin.
Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses.
The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting.
Other Name: IL-2
- Maximum Tolerated Doze of FATE-NK100 [ Time Frame: 1 Year ]To determine the maximum tolerated dose/maximum feasible dose (MTD/MFD) of FATE-NK100 when administered via intraperitoneal catheter in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.
- Objective Response Rate [ Time Frame: Day 28 ]Incidence of objective response rate (ORR) of the FATE-NK100 treatment
- Progression-Free Survival (PFS) [ Time Frame: 6 Months ]Incidence of progression-free survival of treated patients 6 months post-infusion
- Overall Survival (OS) [ Time Frame: 6 Months ]Incidence of overall survival of treated patients 6 months post-infusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213964
|Contact: Kimberly Brunsvoldemail@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Melissa Geller, MD 612-624-0123 firstname.lastname@example.org|
|Principal Investigator: Melissa Geller, MD|
|Principal Investigator:||Melissa Geller, MD, MS||Masonic Cancer Center, University of Minnesota|