agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    20
  • sponsor
    MiNK Therapeutics
Updated on 11 May 2022

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.

Details
Condition Relapsed/Refractory Multiple Myeloma
Treatment agenT-797
Clinical Study IdentifierNCT04754100
SponsorMiNK Therapeutics
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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