A Phase I, single-arm, open label, dose escalation, multicenter study of off-the-shelf natural killer (NK) cells (SAR445419) in participants with relapsed or refractory acute myeloid leukemia (R/R) AML
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - Other CAR (ONC), Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Bhatt, Vijaya
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/search?term=NCT05712278
Summary
Primary
To determine candidate dose(s) of SAR445419 for future development in participants with R/R AML
Secondary
To characterize the overall safety and tolerability profile of SAR445419
Assess neutrophil and platelet recovery
To assess the rate of participants going onto HSCT
Assess the impact of SAR445419 on infection
To assess the preliminary anti-leukemic activity of SAR445419 administered as a single agent at the tested doses in participants with R/R AML.
To assess the preliminary alternative CR rate
To assess the preliminary overall complete remission rate
To assess the preliminary duration of response (DoR)
To assess the preliminary duration of event-free survival (EFS)
To assess the preliminary overall survival rate
To assess the preliminary time to treatment failure (TTF) for participants who did not experience complete remission