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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Monotherapy with agenT-797 | Experimental | 3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion. |
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| Part 2: agenT-797 in Combination with approved ICIs | Experimental | Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| agenT-797 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. | Baseline through 12 months |
| Number Of Dose-limiting Toxicities | Baseline through first 14 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | MiNK Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38281989 | Background | Hadfield MJ, Safran H, Purbhoo MA, Grossman JE, Buell JS, Carneiro BA. Overcoming resistance to programmed cell death protein 1 (PD-1) blockade with allogeneic invariant natural killer T-cells (iNKT). Oncogene. 2024 Mar;43(10):758-762. doi: 10.1038/s41388-024-02948-y. Epub 2024 Jan 29. |
| Label | URL |
|---|---|
| Nivolumab \[Package Insert\]. Princeton, NJ: Bristol Myers Squibb Company: 2014. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Approved ICIs | Drug | Nivolumab and pembrolizumab |
|
| 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. | 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. | 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. | Up to 12 months |
| Incidence Of Panel-reactive Antibody | 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 | 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) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Norton Cancer Health | Louisville | Kentucky | 40241 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| LifeSpan - Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Pembrolizumab \[Package Insert\]. White House Station, NJ: Merck \& Co. Inc.; 2014-2021. | View source |