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Completed

NCT Number: NCT04754100

agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida, Louisville, Kentucky, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

agenT-797

Drug

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

MiNK Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2021
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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