Tumor, Solid
Conditions
Keywords
Tumor, Solid Tumor, Immunotherapy, iNKT cells
Brief summary
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.
Interventions
DRUGagenT-797
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.
DRUGApproved ICIs
Nivolumab and pembrolizumab
Sponsors
MiNK Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological evidence of relapsed or refractory solid tumor malignancy for which no standard therapy is available or standard therapy has failed * Measurable disease per RECIST 1.1 as assessed by local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions * Part 2 only, participants must have progressed per Investigator assessment on pembrolizumab or nivolumab, and agree and are able to continue on the inhibitor(s) while on study * No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the Principal Investigator
Exclusion criteria
* Concurrent invasive malignancy * Brain and/or leptomeningeal metastases that are untreated or require current therapy * Prior radiotherapy within 2 weeks of start of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through 12 months | This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). |
| Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy | Baseline through 12 months | This will be determined according to the NCI CTCAE v5.0. |
| Number Of TEAEs By The Dose Of iNKT Cell Therapy | Baseline through 12 months | This will be determined according to the NCI CTCAE v5.0. |
| Severity Grade Of AEs By Dose Of iNKT Cell Therapy | Baseline through 12 months | This will be determined according to the NCI CTCAE v5.0. |
| Number Of Dose-limiting Toxicities | Baseline through first 14 days after administration | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistence Of agenT-797 In Peripheral Blood Samples | 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 | This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry. |
| 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) | — |
| Objective Response Rate (ORR) | Up to 12 months | 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. |
| Duration Of Response (DOR) | Up to 12 months | 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. |
| Progression-free Survival (PFS) | Up to 12 months | 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. |
| 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) | — |
Countries
United States
Outcome results
None listed