Clinical trial NCT05108623: A Study Investigating agenT-797 in Participants With Relapsed/Refractory Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumor, Solid
Keywords: Tumor
Solid Tumor
Immunotherapy
iNKT cells
Lead sponsor: MiNK Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number Of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline through 12 months
measure: Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy
timeFrame: Baseline through 12 months
measure: Number Of TEAEs By The Dose Of iNKT Cell Therapy
timeFrame: Baseline through 12 months
measure: Severity Grade Of AEs By Dose Of iNKT Cell Therapy
timeFrame: Baseline through 12 months
measure: Number Of Dose-limiting Toxicities
timeFrame: Baseline through first 14 days after administration
Secondary outcomes:
measure: Persistence Of agenT-797 In Peripheral Blood Samples
timeFrame: 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
measure: Objective Response Rate (ORR)
timeFrame: Up to 12 months
measure: Duration Of Response (DOR)
timeFrame: Up to 12 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 12 months
measure: Incidence Of Panel-reactive Antibody
timeFrame: 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)
measure: Incidence Of Donor-specific Antibody
timeFrame: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Louisville
country: United States
facility: Norton Cancer Health
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Providence
country: United States
facility: LifeSpan - Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: MiNK Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.