NCT05108623

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: MiNK Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	agenT-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.
DRUG	Approved ICIs	Nivolumab and pembrolizumab

Timeline

• Start date: 2022-01-28
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2021-11-05
• Last updated: 2024-04-24

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study