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agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754100
Recruitment Status : Active, not recruiting
First Posted : February 15, 2021
Last Update Posted : October 24, 2022
Sponsor:
Information provided by (Responsible Party):
MiNK Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 29, 2021
Actual Primary Completion Date : September 30, 2022
Estimated Study Completion Date : April 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.




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) ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754100


Locations
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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
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Study Director: Medical Director MiNK Therapeutics
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Responsible Party: MiNK Therapeutics
ClinicalTrials.gov Identifier: NCT04754100    
Other Study ID Numbers: 2019-1305
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022

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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:
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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