agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Relapsed/Refractory Multiple Myeloma

Intervention / Treatment
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* Drug: agenT-797


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic iNKT Cells<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline through Day 28 post cell infusion | 
| Number Of Dose-limiting Toxicities |  | Baseline through Day 14 post cell infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iNKT cells, Multiple myeloma, Immunotherapy