A Phase 1, Open-Label Study of the Safety, Tolerability, and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) in Subjects With Relapsed/Refractory Multiple Myeloma

MiNK Therapeutics3 sites in 1 country13 target enrollmentMarch 29, 2021

ConditionsRelapsed/Refractory Multiple Myeloma

InterventionsagenT-797

DrugsagenT-797

Overview

Phase: Phase 1
Intervention: agenT-797
Conditions: Relapsed/Refractory Multiple Myeloma
Sponsor: MiNK Therapeutics
Enrollment: 13
Locations: 3
Primary Endpoint: Number Of Participants With Treatment-related Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 or refractory multiple myeloma, as well as to define the recommended Phase 2 dose.

Registry

clinicaltrials.gov

Start Date

March 29, 2021

End Date

May 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

MiNK Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Relapsed/Refractory Multiple Myeloma
•Confirmed diagnosis and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group criteria and following prior therapy for multiple myeloma (MM)
•Relapsed or refractory MM requiring current treatment
•Previously failed ≥ 3 prior regimens (after at least 2 cycles of medication per regimen) and included at least 1 immunomodulatory drug, 1 proteasome inhibitor, and an anti-CD38 antibody agent
•Participants must have measurable disease as defined by at least 1 of the following:
•Serum M-protein ≥ 0.5 grams/deciliter (dL) by serum protein electrophoresis or for immunoglobulin A (IgA) myeloma, by quantitative IgA; or
•Urinary M-protein excretion at least 200 milligrams (mg)/24 hours; or
•Serum free light chain whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio
•Estimated life expectancy ≥ 3 months
•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
•Participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agenT-797
•Prior radiotherapy within 2 weeks of start of study treatment
•Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug

Arms & Interventions

Allogeneic iNKT Cells

3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days \[2 weeks\]).

Intervention: agenT-797

Outcomes

Primary Outcomes

Number Of Participants With Treatment-related Adverse Events

Time Frame: Baseline through Day 28 post cell infusion

This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.

Number Of Dose-limiting Toxicities

Time Frame: Baseline through Day 14 post cell infusion

Secondary Outcomes

Persistence Of agenT-797 In Peripheral Blood(Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0,5, 1, 2, and 4 hours post cell infusion), Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12)
Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II(Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months))
Overall Response Rate (ORR)(End of study visit (up to 12 months))
Duration Of Response (DOR)(End of study visit (up to 12 months))
Duration Of Clinical Benefit(End of study visit (up to 12 months))
Time To Response (TTR)(End of study visit (up to 12 months))