Back to resultsagenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
Primary Purpose
Relapsed/Refractory Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
agenT-797
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring Multiple myeloma, Immunotherapy, iNKT cells
Eligibility Criteria
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
Sites / Locations
- Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
- Dana-Farber Cancer Institute
- University of Cincinnati Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogeneic iNKT Cells
Arm Description
3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days [2 weeks]).
Outcomes
Primary Outcome Measures
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.
Number Of Dose-limiting Toxicities
Secondary Outcome Measures
Persistence Of agenT-797 In Peripheral Blood
Overall Response Rate (ORR)
Duration Of Response (DOR)
Duration Of Clinical Benefit
Time To Response (TTR)
Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04754100
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
January 13, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiNK Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
Multiple myeloma, Immunotherapy, iNKT cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allogeneic iNKT Cells
Arm Type
Experimental
Arm Description
3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days [2 weeks]).
Intervention Type
Drug
Intervention Name(s)
agenT-797
Intervention Description
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 Measure Information:
Title
Number Of Participants With Treatment-related Adverse Events
Description
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Time Frame
Baseline through Day 28 post cell infusion
Title
Number Of Dose-limiting Toxicities
Time Frame
Baseline through Day 14 post cell infusion
Secondary Outcome Measure Information:
Title
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
Title
Overall Response Rate (ORR)
Time Frame
End of study visit (up to 12 months)
Title
Duration Of Response (DOR)
Time Frame
End of study visit (up to 12 months)
Title
Duration Of Clinical Benefit
Time Frame
End of study visit (up to 12 months)
Title
Time To Response (TTR)
Time Frame
End of study visit (up to 12 months)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
MiNK Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Cincinnati Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
12. IPD Sharing Statement
Learn more about this trial
agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
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