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

NCT05108623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-04-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MiNK Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Director · MiNK Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2024-01-02
Completion
2024-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108623 on ClinicalTrials.gov