Your session is about to expire
← Back to Search
CAR T-cell Therapy
FT516 and IL2 With Enoblituzumab for Ovarian Cancer
Phase 1
Waitlist Available
Led By Melissa Geller, MD, MS
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year from the first dose of ft516
Awards & highlights
No Placebo-Only Group
Summary
This trial tests FT516, a treatment using special immune cells, in patients with recurrent ovarian cancer. The treatment includes enoblituzumab to help the immune system recognize cancer cells and IL-2 to support NK cell survival. Chemotherapy is given beforehand to prepare the body.
Eligible Conditions
- Ovarian Cancer
- Peritoneal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year from the first dose of ft516
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year from the first dose of ft516
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Experiencing Adverse Events
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Secondary study objectives
Number of Participants Experiencing Overall Survival
Number of Participants Experiencing Progression Free Survival
Side effects data
From 2022 Phase 1 trial • 3 Patients • NCT04630769100%
Weight loss
100%
Hypocalcemia
100%
Hypoalbuminemia
100%
Hyperglycemia
100%
Anorexia
100%
Abdominal pain
100%
Pain
100%
Chills
100%
Alanine aminotransferase increased
100%
Alkaline phosphatase increased
100%
Bloating
100%
Lymphocyte count decreased
100%
Neoplasms benign, malignant and
100%
Anemia
100%
Vomiting
100%
Flatulence
100%
Fatigue
100%
Fever
100%
Platelet count decreased
100%
White blood cell decreased
100%
Aspartate aminotransferase increased
100%
Proteinuria
100%
Dyspnea
100%
Pruritus
100%
Constipation
100%
Nausea
100%
Hyponatremia
100%
Myalgia
100%
Headache
100%
Insomnia
100%
Hematoma
100%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Monotherapy: IP FT516 at 9 x 10^8 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 9 x 10^7 Cells/Dose on Day 1, 8, and 15
Monotherapy: IP FT516 at 3 x 10^8 Cells/Dose on Day 1, 8, and 15
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Safe dose (MTD-1) from 1st 3 levels + IV enoblituzumab on Day -6Experimental Treatment3 Interventions
Group II: Monotherapy: IP FT516 at 9 x 10^8 cells/dose on Day 1, 8, and 15Experimental Treatment2 Interventions
Group III: Monotherapy: IP FT516 at 9 x 10^7 cells/dose on Day 1, 8, and 15Experimental Treatment2 Interventions
Group IV: Monotherapy: IP FT516 at 3 x 10^8 cells/dose on Day 1, 8, and 15Experimental Treatment2 Interventions
Group V: Highest dose (MTD) from 1st 3 levels + IV enoblituzumab on Day -6Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IP FT516
2021
Completed Phase 1
~10
Enoblituzumab
2021
Completed Phase 1
~180
IL-2
2007
Completed Phase 4
~1100
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
281 Previous Clinical Trials
15,604 Total Patients Enrolled
22 Trials studying Ovarian Cancer
588 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,185 Total Patients Enrolled
289 Trials studying Ovarian Cancer
76,720 Patients Enrolled for Ovarian Cancer
Melissa Geller, MD, MSPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
1 Previous Clinical Trials
10 Total Patients Enrolled