agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Drug: agenT-797

• Registration Number: NCT04754100
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-03-29
• Primary Completion: 2023-01-13
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-05
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Allogeneic iNKT Cells	agenT-797	3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days \[2 weeks\]).

Primary Outcome Measures

Name	Time	Method
Number Of Participants With Treatment-related Adverse Events	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	Baseline through Day 14 post cell infusion

Secondary Outcome Measures

Name	Time	Method
Persistence Of agenT-797 In Peripheral Blood	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
Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II	Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months)
Overall Response Rate (ORR)	End of study visit (up to 12 months)
Duration Of Response (DOR)	End of study visit (up to 12 months)
Duration Of Clinical Benefit	End of study visit (up to 12 months)
Time To Response (TTR)	End of study visit (up to 12 months)

Trial Locations

Locations (3)

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

University of Cincinnati Cancer Center; 🇺🇸 Cincinnati, Ohio, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States