Biotechnology company T-MAXIMUM Pharmaceutical announced on Sunday that it has received IND clearance from the US Food and Drug Administration (FDA) to commence a Phase II clinical trial of MT027 for the treatment of recurrent glioblastoma (rGBM).

MT027 is an 'off-the-shelf' allogeneic CAR-T product sourced from healthy donors and designed to target B7-H3 for the treatment of rGBM. As an allogeneic therapy, MT027 enables large-scale manufacturing and cryopreservation, allowing patients to receive treatment rapidly without the delays associated with autologous cell production - an advantage that can be critical for individuals facing fast-progressing and life-threatening diseases.

Dr. Xiaoyun Shang, T-MAXIMUM Pharmaceutical founder and CEO, said: "The FDA's clearance of the IND for MT027 represents a strong validation of our strategic commitment to tackling the most challenging solid tumours. This milestone is not only a small step for T-MAXIMUM, but a significant leap forward for the entire cell therapy field as we push into the 'uncharted territory' of solid tumour treatment."