Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
agenT-797 · 3 trials · 3 indications
This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
This will be determined according to the NCI CTCAE v5.0.
This will be determined according to the NCI CTCAE v5.0.
This will be determined according to the NCI CTCAE v5.0.
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
| Arm | Type | Description |
|---|---|---|
| Part 1: Monotherapy with agenT-797 | EXPERIMENTAL | 3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion. |
| 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 |
| Allogeneic iNKT Cells | EXPERIMENTAL | 3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days \[2 weeks\]). |
| Dosage and Cohorts | EXPERIMENTAL | Cohort 1: 100 × 10\^6 iNKT cells; Cohort 2: 300 × 10\^6 iNKT cells; Cohort 3: 1000 × 10\^6 iNKT cells Dosage Frequency and Mode of Administration: agenT-797 will be administered to hospitalized participants as a single intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| 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. |
| Approved ICIs | DRUG | Nivolumab and pembrolizumab |
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 previousl...
agenT-797 is an investigational small molecule being studied for use in oncology and respiratory conditions. Clinical trials have evaluated it in adults with relapsed/refractory multiple myeloma, relapsed/refractory solid tumors, and adult respiratory distress syndrome (ARDS) associated with COVID-19. It is not yet approved and remains in clinical development.
agenT-797 is being developed by MiNK Therapeutics, Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol INKT. The company is conducting clinical research on this investigational agent across multiple indications.
agenT-797 is in Phase 1 clinical development. All three completed trials for this agent were Phase 1 studies, meaning it is still in the early stages of clinical testing and has not been approved by regulatory authorities.
agenT-797 has been studied in three completed Phase 1 trials. NCT04582201 evaluated it in 20 adults with ARDS related to COVID-19. NCT04754100 studied it in 13 participants with relapsed/refractory multiple myeloma. NCT05108623 investigated it in 34 participants with relapsed/refractory solid tumors.
agenT-797 is the investigational name used by MiNK Therapeutics for this small molecule agent. No alternative names have been disclosed in the clinical trial records, and it is identified consistently as agenT-797 across all studies.