T-MAXIMUM Pharmaceutical's allogeneic CAR-T therapy MT027 receives FDA IND clearance to proceed to Phase II clinical trial for recurrent glioblastoma
T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial for the treatment of recurrent glioblastoma (rGBM).
This milestone marks a significant breakthrough in addressing one of the most formidable challenges in oncology: developing effective allogeneic CAR-T therapies for solid tumors. Leveraging its mature allogeneic technology platform, T-MAXIMUM Pharmaceutical is concurrently developing additional clinical programs targeting brain metastases and other solid tumors, further expanding its therapeutic pipeline.
MT027 is an "off-the-shelf" allogeneic CAR-T product sourced from healthy donors and designed to target B7-H3 for the treatment of recurrent glioblastoma.
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.
Unlike many industry peers relying on lentiviral or retroviral vectors, T-MAXIMUM Pharmaceutical has achieved a major advancement during the product's transition to registration-oriented clinical development—establishing a fully non-viral gene-editing platform. This innovation enhances product safety while improving manufacturing precision and controllability, representing the next generation of cell therapy engineering.