This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. This Phase 1 study will also explore the safety, tolerability, and preliminary clinical activity of agenT-797 in combination with approved immune checkpoint inhibitors (ICIs), including pembrolizumab and nivolumab, in participants with r/r solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.
Nivolumab and pembrolizumab
University of Southern California
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Norton Cancer Health
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Number Of Participants With Treatment-emergent Adverse Events (TEAEs)
This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Time frame: Baseline through 12 months
Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy
This will be determined according to the NCI CTCAE v5.0.
Time frame: Baseline through 12 months
Number Of TEAEs By The Dose Of iNKT Cell Therapy
This will be determined according to the NCI CTCAE v5.0.
Time frame: Baseline through 12 months
Severity Grade Of AEs By Dose Of iNKT Cell Therapy
This will be determined according to the NCI CTCAE v5.0.
Time frame: Baseline through 12 months
Number Of Dose-limiting Toxicities
Time frame: Baseline through first 14 days after administration
Persistence Of agenT-797 In Peripheral Blood Samples
This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.
Time frame: Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0.5, 1, 2, and 4 hours after cell infusion), and on Days 2, 5, 8, 15, 22, and 29; Weeks 6, 8, and 12; and Months 6, 9, and 12
Objective Response Rate (ORR)
For solid tumors, this will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), Prostate Cancer Working Group 3 (PCWG3) will be used.
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University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
LifeSpan - Rhode Island Hospital
Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Time frame: Up to 12 months
Duration Of Response (DOR)
For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.
Time frame: Up to 12 months
Progression-free Survival (PFS)
For solid tumors, this will be determined per RECIST 1.1 guidelines and for prostate cancer (not evaluable per RECIST 1.1), PCWG3 will be used.
Time frame: Up to 12 months
Incidence Of Panel-reactive Antibody
Time frame: Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months)
Incidence Of Donor-specific Antibody
Time frame: Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months)