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

NCT05108623 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2021-1306
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Tumor; Solid Tumor; Immunotherapy; iNKT cells

Outcome Measures

Primary Outcomes (5)

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

  This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).

  Baseline through 12 months

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

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

  Baseline through 12 months

• Number Of TEAEs By The Dose Of iNKT Cell Therapy

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

  Baseline through 12 months

• Severity Grade Of AEs By Dose Of iNKT Cell Therapy

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

  Baseline through 12 months

• Number Of Dose-limiting Toxicities

  Baseline through first 14 days after administration

Secondary Outcomes (6)

• Persistence Of agenT-797 In Peripheral Blood Samples

  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

• Objective Response Rate (ORR)

  Up to 12 months

• Duration Of Response (DOR)

  Up to 12 months

• Progression-free Survival (PFS)

  Up to 12 months

• Incidence Of Panel-reactive Antibody

  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)

Study Arms (2)

Part 1: Monotherapy with agenT-797

EXPERIMENTAL

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

Drug: agenT-797

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

Drug: agenT-797; Drug: Approved ICIs

Interventions

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.

Part 1: Monotherapy with agenT-797; Part 2: agenT-797 in Combination with approved ICIs

Approved ICIs DRUG

Nivolumab and pembrolizumab

Part 2: agenT-797 in Combination with approved ICIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MiNK Therapeutics: lead

Study Sites (8)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Norton Cancer Health

Louisville, Kentucky, 40241, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

LifeSpan - Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

• Hadfield MJ, Safran H, Purbhoo MA, Grossman JE, Buell JS, Carneiro BA. Overcoming resistance to programmed cell death protein 1 (PD-1) blockade with allogeneic invariant natural killer T-cells (iNKT). Oncogene. 2024 Mar;43(10):758-762. doi: 10.1038/s41388-024-02948-y. Epub 2024 Jan 29.

  PMID: 38281989 BACKGROUND

Related Links

• Nivolumab \[Package Insert\]. Princeton, NJ: Bristol Myers Squibb Company: 2014.
• Pembrolizumab \[Package Insert\]. White House Station, NJ: Merck \& Co. Inc.; 2014-2021.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Medical Director

  MiNK Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 5, 2021
• Study Start: January 28, 2022
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (8)