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

Tracking Information

• First Submitted Date: February 3, 2021
• First Posted Date: February 15, 2021
• Last Update Posted Date: June 6, 2023
• Actual Study Start Date: March 29, 2021
• Actual Primary Completion Date: January 13, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2022)

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

Original Primary Outcome Measures (submitted: February 10, 2021)

• Incidence of AEs [ Time Frame: Up to day 28 post cell infusion. ]
  Number of participants with treatment-related AEs as determined per NIC CTCAE v5.0
• Correlation of the dose of iNKT cell therapy with the incidence, nature, and intensity of AEs. [ Time Frame: Up to day 28 post cell infusion. ]
  Evaluation of AEs at each dose level.
• Recommended Phase 2 dose [ Time Frame: 28 days post cell infusion ]
  Maximum Tolerated Dose (MTD) based on DLT occurence at DLT period (28 days after cell infusion).

Current Secondary Outcome Measures (submitted: April 21, 2022)

• 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 ]
• Overall Response Rate (ORR) [ Time Frame: End of study visit (up to 12 months) ]
• Duration Of Response (DOR) [ Time Frame: End of study visit (up to 12 months) ]
• Duration Of Clinical Benefit [ Time Frame: End of study visit (up to 12 months) ]
• Time To Response (TTR) [ Time Frame: End of study visit (up to 12 months) ]
• 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) ]

Original Secondary Outcome Measures (submitted: February 10, 2021)

• Persistence of allogeneic iNKT cells. [ Time Frame: Baseline, 2 hours post cell infusion, and on Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12. ]
  Persistence of agenT-797 in peripheral blood (SNP-based assay)
• Clinical response evaluation. [ Time Frame: End of study visit (up to 12 months). ]
  Evaluation using the International Myeloma Working Group (IMWG) consensus criteria.
• Evaluation of immune response to donor cells [ Time Frame: Baseline, Day 22, Week 6 and end of study visit (up to 12 months). ]
  Measurement of serum alloantibodies to MHC Class I and II

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Relapsed/Refractory Multiple Myeloma

Intervention

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.

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]).

Intervention: Drug: agenT-797

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2023): 13
• Original Estimated Enrollment (submitted: February 10, 2021): 30
• Actual Study Completion Date: May 31, 2023
• Actual Primary Completion Date: January 13, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04754100
• Other Study ID Numbers: 2019-1305
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: MiNK Therapeutics
• Original Responsible Party: AgenTus Therapeutics, Inc.
• Current Study Sponsor: MiNK Therapeutics
• Original Study Sponsor: AgenTus Therapeutics, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; MiNK Therapeutics

• PRS Account: MiNK Therapeutics
• Verification Date: June 2023