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CompletedNCT04754100Updated Jun 6, 2023

agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

A Phase 1 interventional study of agenT-797 in Relapsed/Refractory Multiple Myeloma, sponsored by MiNK Therapeutics. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.

Sponsored by MiNK Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2023, 3 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed/Refractory Multiple Myeloma

Keywords

  • Multiple myeloma
  • Immunotherapy
  • iNKT cells
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 13 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

MiNK Therapeutics is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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

Interventions

  • DrugagenT-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.

06

What researchers measure

Primary outcomes

  1. Number Of Participants With Treatment-related Adverse Events

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

    Time frame: Baseline through Day 28 post cell infusion

  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)

07

Study locations

3 sites
  • Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
    Louisville, Kentucky 40207, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • University of Cincinnati Cancer Center
    Cincinnati, Ohio 45267, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04754100
Lead sponsor
MiNK Therapeutics
Responsible party
Sponsor
First posted
Feb 15, 2021
Start date
Mar 29, 2021
Primary completion
Jan 13, 2023
Completion
May 31, 2023
Last update
Jun 6, 2023

Study contacts

Medical Director
study director · MiNK Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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