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

Tumor, Solid Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108623
• Other study ID #: 2021-1306
• Status: Completed
• Phase: Phase 1
• Start date: January 28, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: April 2024
• Source: MiNK Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Tumor, Solid

Intervention

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.
• Approved ICIs
Nivolumab and pembrolizumab

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Cincinnati Cancer Center	Cincinnati	Ohio
United States	University of Southern California	Los Angeles	California
United States	Norton Cancer Health	Louisville	Kentucky
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Providence Portland Medical Center	Portland	Oregon
United States	LifeSpan - Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
MiNK Therapeutics

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number Of Dose-limiting Toxicities		Baseline through first 14 days after administration
Secondary	Persistence Of agenT-797 In Peripheral Blood Samples	This will be measured as a length of time, through collection of peripheral blood mononuclear cells and analysis by flow cytometry.	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
Secondary	Objective Response Rate (ORR)	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.	Up to 12 months
Secondary	Duration Of Response (DOR)	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.	Up to 12 months
Secondary	Progression-free Survival (PFS)	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.	Up to 12 months
Secondary	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)
Secondary	Incidence Of Donor-specific 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)

External Links

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