Trial Outcomes & Findings for FT516 and IL2 With Enoblituzumab for Ovarian Cancer (NCT NCT04630769)

Last Updated: 2023-04-03

Results Overview

DLT is defined as any treatment emergent toxicity at least possibly related to the study treatment meeting one of the following criteria based on CTCAE v5 within 28 days (14 days for ascites) of the 1st FT516 infusion (for Cohort 4 and 5, DLT assessment starts with enoblituzumab and continues for 28 days after 1st FT516): Grade 3 organ toxicity (pulmonary, hepatic, renal, or neurologic) not pre-existing and lasting more than 72 hours , Any non-hematologic Grade 4 or 5 toxicity, Neutrophil count decreased ≥ Grade 4 that persists at Day 28 despite use of growth factor support ,Grade 3 abdominal pain lasting more than 4 consecutive days and not controlled by standard analgesics, Grade 3 or greater ascites within 14 days after FT516 administration in patients who had no ascites or Grade 1 ascites at enrollment and is not attributable to disease progression

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

3 participants

Primary outcome timeframe

28 Days Post FT516 infusion

Results posted on

2023-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Overall Study STARTED	1	1	1
Overall Study COMPLETED	1	1	1
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FT516 and IL2 With Enoblituzumab for Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation Enoblituzumab: Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3 which is highly expressed on ovarian cancer. Enoblituzumab at 15 mg/kg IV, one day before lymphodepleting chemotherapy IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation Enoblituzumab: Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3 which is highly expressed on ovarian cancer. Enoblituzumab at 15 mg/kg IV, one day before lymphodepleting chemotherapy IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	—	—	3 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	—	—	3 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	—	—	3 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	—	—	3 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	—	—	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: 28 Days Post FT516 infusion

Outcome measures

Outcome measures
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Experimental: Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: 28 days after first dose of FT516 or 28 days after last dose of Enoblituzumab (arm 4 and 5 only)

Population: No participants were enrolled in the "Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6" and "Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6" arms.

Number of participants experiencing adverse events related to FT516

Outcome measures

Outcome measures
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Experimental: Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Number of Participants Experiencing Adverse Events	1 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 6 months from the first dose of FT516

Population: No data collected as no participants were on study at 6 months from first dose of FT516 in the "Monotherapy: IP FT516 at 9 x 10\^7 cells/dose on Day 1, 8, and 15" and "Monotherapy: IP FT516 at 9 x 10\^8 cells/dose on Day 1, 8, and 15" arms. No data collected as no participants were enrolled in the "Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6" and "Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6" arms.

Number of participants experiencing progression free survival at 6 months from the first dose of FT516

Outcome measures

Outcome measures
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Experimental: Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Number of Participants Experiencing Progression Free Survival	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 year from the first dose of FT516

Population: No data collected as no participants were enrolled in the "Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6" and "Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6" arms. No data collected as no participants were on study at 1 year from first dose of FT516 for all remaining arms.

Number of participants experiencing progression free survival at 1 year from the first dose of FT516

Outcome measures

Outcome measures
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Experimental: Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Number of Participants Experiencing Progression Free Survival	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 6 months from the first dose of FT516

Number of participants experiencing overall survival at 6 months from the first dose of FT516

Outcome measures

Outcome measures
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Experimental: Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Number of Participants Experiencing Overall Survival	0 Participants	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 1 year from the first dose of FT516

Number of participants experiencing overall survival at 1 year from the first dose of FT516

Outcome measures

Outcome measures
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 Participants IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Experimental: Safe Dose (MTD-1) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Highest Dose (MTD) From 1st 3 Levels + IV Enoblituzumab on Day -6 IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Number of Participants Experiencing Overall Survival	0 Count of Participants	0 Count of Participants	0 Count of Participants	—	—

Adverse Events

Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15 n=1 participants at risk IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 participants at risk IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.	Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15 n=1 participants at risk IP FT516: FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation IL-2: IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is \<45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
Gastrointestinal disorders Nausea	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
Gastrointestinal disorders Small intestinal obstruction	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
General disorders Pain	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
Infections and infestations Infections and infestations - Other,	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
Nervous system disorders Headache	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.
Vascular disorders Thromboembolic event	100.0% 1/1 • Number of events 1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.	0.00% 0/1 • Adverse events were assessed through day 28 after the 1st dose of FT516. After day 28, All-Cause Mortality was assessed up to approximately 9 months from the first dose of FT516.

Other adverse events

Additional Information

Melissa Geller, MD

Masonic Cancer Center, University of Minnesota

Phone: 612-626-3111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place