Antineoplastic Agents

All Drugs and Chemicals

Immune Checkpoint Inhibitors

Pembrolizumab

Immunomodulating Agents

Nivolumab

3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.

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

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.

agenT-797

Approved ICIs

Medical Director

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.

A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors

A Phase 1, Open-Label Study of the Safety, Tolerability and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) as a Single Agent and in Combination With Approved Immune Checkpoint Inhibitors in Patients With Relapsed/ Refractory Solid Tumors

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 measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors	NCT05108623	Tumor, Solid	agenT-797 Approved ICIs	18 Years -	MiNK Therapeutics
A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors	NCT05108623	Tumor, Solid	agenT-797 Approved ICIs	18 Years -	MiNK Therapeutics

Spots Global Cancer Trial Database for approved icis