Status:
COMPLETED
agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
MiNK Therapeutics
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 r...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04754100
Start Date
March 29 2021
End Date
May 31 2023
Last Update
June 6 2023
Active Locations (3)
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1
Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
Louisville, Kentucky, United States, 40207
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
3
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267