Oral Presentation ISCT ANZ - BAA Joint Scientific Meeting 2022

Phase I clinical trial of point-of-care manufactured CD19 Chimeric Antigen Receptor (CAR) T cells (80425)

Siok Tey 1
  1. Department of Haematology and Bone Marrow Transplantation, Royal Brisbane and Women’s Hospital, Medical Director, Q-Gen Cell Therapeutics,, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia

There are currently two types of CD19 Chimeric Antigen Receptor (CAR) T cell therapy that are approved for routine clinical use in Australia: tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta).   However, the clinical need and utility exceed the currently approved indications, and the typical turnaround time of at least four weeks make it challenging to deliver timely treatment.  In 2019 / 2020, the Royal Brisbane and Women’s Hospital (RBWH), in collaboration with QIMR Berghofer Medical Research Institute, initiated a program to manufacture CD19 CAR T cells at “point-of-care”.  This project uses the Miltenyi CliniMACS Prodigy system and aims to reduce turnaround time and broaden access.  In July 2021, we opened a phase I clinical trial for adults with relapsed or refractory CD19-positive malignancies who are ineligible for government-funded standard-of-care CAR T cell therapy.  Here, we will share our learnings from this experience and present early data from our first three patients.