agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

Sponsor

MiNK Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04754100

Collaborator

(none)

Enrollment

Locations

Arm

24.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Multiple Myeloma	Drug: agenT-797	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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) in Subjects With Relapsed/Refractory Multiple Myeloma

Actual Study Start Date :

Mar 29, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Apr 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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]).	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.

Arm

Intervention/Treatment

Experimental: 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]).

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.

Outcome Measures

Primary Outcome Measures

Number Of Participants With Treatment-related Adverse Events [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 [Baseline through Day 14 post cell infusion]

Secondary Outcome Measures

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]
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)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key 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

Key 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida	Louisville	Kentucky	United States	40207
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

MiNK Therapeutics

Investigators

Study Director: Medical Director, MiNK Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MiNK Therapeutics

ClinicalTrials.gov Identifier:

NCT04754100

Other Study ID Numbers:

2019-1305

First Posted:

Feb 15, 2021

Last Update Posted:

Jul 25, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by MiNK Therapeutics

Multiple myeloma

Immunotherapy

iNKT cells

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Jul 25, 2022