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Completed

NCT Number: NCT05108623

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

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.

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Key information

Conditions

Tumor, Solid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Southern California, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number Of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: 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).

  2. Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy

    Time frame: Baseline through 12 months

    This will be determined according to the NCI CTCAE v5.0.

  3. Number Of TEAEs By The Dose Of iNKT Cell Therapy

    Time frame: Baseline through 12 months

    This will be determined according to the NCI CTCAE v5.0.

  4. Severity Grade Of AEs By Dose Of iNKT Cell Therapy

    Time frame: Baseline through 12 months

    This will be determined according to the NCI CTCAE v5.0.

  5. Number Of Dose-limiting Toxicities

    Time frame: Baseline through first 14 days after administration

Secondary outcomes

  1. Persistence Of agenT-797 In Peripheral Blood Samples

    Time frame: 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.

  2. Objective Response Rate (ORR)

    Time frame: 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.

  3. Duration Of Response (DOR)

    Time frame: 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.

  4. Progression-free Survival (PFS)

    Time frame: 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.

  5. Incidence Of Panel-reactive Antibody

    Time frame: 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)

  6. Incidence Of Donor-specific Antibody

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

MiNK Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2021
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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