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. 2021 Sep 16;9(9):e003149. doi: 10.1136/jitc-2021-003149

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© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/.

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Preclinical validation of anti-leukemia activity of clinical-grade CD33 chimeric antigen receptor construct (CD33CART). The lintuzumab-based CD33CART with a CD28/CD3ζendodomain (lin-28z) was selected for further development and evaluation in a phase 1 clinical trial. (A) Transduction efficiency of clinical grade lin-28z CD33CART was 30.3% for this experiment. (B) Luciferase-transduced MOLM14 cells (1×10⁶) were injected intravenous into NSG mice on day 0. Animals were assessed by bioluminescent imaging (BLI) and then randomized to treatment with GFP-transduced T cells ((-)TC) or clinical-grade lin-28z CD33CART cells (5×10⁶ total cells/mouse) on day 3 (red arrow). Mice were followed by weekly BLI and euthanized when a predetermined maximal radiance level of 1×10¹⁰ photons/s/cm²/sr was detected Complete inhibition of leukemia proliferation was again observed with CD33CART.