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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida
Louisville, Kentucky, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
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.
Time frame: Baseline through Day 28 post cell infusion
Number Of Dose-limiting Toxicities
Time frame: Baseline through Day 14 post cell infusion
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)
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