This trial represents the fourth program from CREATE’s platform to enter clinical development and serves as the company's inaugural venture outside of oncology. Unlike conventional CAR-T therapies that require complex ex-vivo cell manufacturing, CRT-402 utilizes an mRNA-LNP platform to program a patient's T cells directly within the body. By targeting CD19, the treatment aims to deplete autoreactive B cells and induce disease remission.

Daniel Getts, CEO and co-founder of CREATE, noted that the move into autoimmune diseases leverages existing clinical data from the company's oncology programs. Professor Merrilee Needham, the trial’s principal investigator at Fiona Stanley Hospital, emphasized that the therapy’s potential for deep B-cell depletion and its off-the-shelf administration could significantly improve accessibility compared to current standards of care. Preclinical results in non-human primates previously demonstrated sustained B-cell depletion, providing the foundation for the upcoming human study.