agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT04754100
• Recruitment Status: Completed
• First Posted: February 15, 2021
• Last Update Posted: June 6, 2023
• Sponsor: MiNK Therapeutics
• Information provided by (Responsible Party): MiNK Therapeutics

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 (Clinical Trial)
• Actual Enrollment: 13 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: March 29, 2021
• Actual Primary Completion Date: January 13, 2023
• Actual Study Completion Date: May 31, 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Number Of Dose-limiting Toxicities [ Time Frame: Baseline through Day 14 post cell infusion ]

Secondary Outcome Measures :

1. Persistence Of agenT-797 In Peripheral Blood [ Time Frame: 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 ]
2. Overall Response Rate (ORR) [ Time Frame: End of study visit (up to 12 months) ]
3. Duration Of Response (DOR) [ Time Frame: End of study visit (up to 12 months) ]
4. Duration Of Clinical Benefit [ Time Frame: End of study visit (up to 12 months) ]
5. Time To Response (TTR) [ Time Frame: End of study visit (up to 12 months) ]
6. Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II [ Time Frame: Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria:

1. Relapsed/Refractory Multiple Myeloma

   1. 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)
   2. Relapsed or refractory MM requiring current treatment
   3. 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

   4. 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
2. Estimated life expectancy ≥ 3 months
3. 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:

1. Concurrent invasive malignancy
2. 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
3. Prior radiotherapy within 2 weeks of start of study treatment
4. Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug

Contacts and Locations

Locations

United States, Kentucky

Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida

Louisville, Kentucky, United States, 40207

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Ohio

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States, 45267

Sponsors and Collaborators

MiNK Therapeutics

Investigators

• Study Director: Medical Director; MiNK Therapeutics

More Information

• Responsible Party: MiNK Therapeutics
• ClinicalTrials.gov Identifier: NCT04754100
• Other Study ID Numbers: 2019-1305
• First Posted: February 15, 2021
• Last Update Posted: June 6, 2023
• Last Verified: June 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MiNK Therapeutics:

Multiple myeloma; Immunotherapy; iNKT cells

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases