11
Participants
Start Date
August 4, 2017
Primary Completion Date
October 10, 2019
Study Completion Date
October 10, 2019
Leukapheresis
After enrollment, steady state leukapheresis performed to collect apheresis material. The goal is to achieve a target total nucleated cell (TNC) yield of at least 5 x 10\^9 (expected range 5 x 10\^8 - 5 x 10\^10), for up to two days.
Fludarabine
25 mg/m2 administered by vein on Days -5 to -3.
Cyclophosphamide
900 mg/m2 administered by vein on Day -3.
CD33-CAR-T Cell Infusion
CD33-CAR-T cell infusion administered by vein on Day 0. First group of participants receive the lowest dose level. Each new group will receive a higher dose than the one before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of T-cells is found. Starting dose level is \> 1.5 x 105/kg but ≤ 4.5 x 105/kg.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Intrexon Corporation
INDUSTRY
M.D. Anderson Cancer Center
OTHER