T-MAXIMUM Pharmaceutical's Allogeneic CAR-T Therapy MT027 Receives FDA IND Clearance to Proceed to Phase II clinical Trial for Recurrent Glioblastoma

BEIJING, Dec. 21, 2025 /PRNewswire/ -- 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.

"The FDA's clearance of the IND for MT027 represents a strong validation of our strategic commitment to tackling the most challenging solid tumors," said Dr. Xiaoyun Shang, Founder and CEO of T-MAXIMUM Pharmaceutical. "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 tumor treatment. The successful development and advancement of MT027 is grounded in our deep understanding of immunology and our decisive investment in allogeneic cell-editing technologies. As a technology-driven company, T-MAXIMUM Pharmaceutical will continue to uphold a rigorous and pragmatic scientific approach, steadily advancing the clinical development of MT027. We remain committed to breaking new ground in the unexplored landscape of solid tumor cell therapy and using the power of science to win more time for patients."

About MT027

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.

CAR-T therapies have revolutionized treatment for hematologic malignancies; however, progress in solid tumors has been notably slower—particularly in glioblastoma, where the blood-brain barrier, intratumoral heterogeneity, and immunosuppressive microenvironment pose unique challenges. FDA IND clearance enabling MT027 to enter Phase II clinical evaluation represents a milestone step in advancing allogeneic CAR-T technology toward one of the most difficult solid tumor indications.

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.

About Glioblastoma

Glioblastoma (GBM) is among the most aggressive and lethal cancers of the central nervous system, often referred to as the "Mount Everest" of neurosurgery. Despite widespread adoption of the standard Stupp regimen, median overall survival remains only 14–16 months, with a five-year survival rate below 5%. For patients with recurrent glioblastoma, treatment options are even more limited, with median survival typically less than 6–9 months. There remains a profound unmet medical need in this area.

Since its founding, T-MAXIMUM Pharmaceutical has focused its research and development strategy on addressing these unmet needs, deliberately steering away from highly competitive hematologic indications to confront the formidable challenge of glioblastoma. This regulatory achievement validates the feasibility and potential of the company's platform.

About T-MAXIMUM Pharmaceutical

T-MAXIMUM Pharmaceutical is an innovative biotechnology company dedicated to the development of allogeneic, off-the-shelf cell therapies, with a mission to address diseases for which there are currently no effective treatments. The company brings together a seasoned team with expertise in immunotherapy, gene editing, and biopharmaceutical industrialization. Leveraging its fully proprietary gene-edited allogeneic immune cell platform, T-MAXIMUM has successfully overcome key challenges in allogeneic cell therapy, including graft-versus-host disease (GvHD) and immune rejection, enabling durable in-vivo persistence and therapeutic efficacy of CAR-T cells.

T-MAXIMUM is currently focused on late-stage malignant tumors, and its lead program for recurrent glioma has received clearance to enter Phase II clinical trials. Over the next three years, the company aims to advance at least one product toward marketing approval and progress multiple programs into Phase II clinical development.

Guided by the principles of integrity, innovation, and collaborative excellence, T-MAXIMUM Pharmaceutical remains committed to clinical value and original innovation. The company continues to pioneer breakthroughs in solid tumor cell therapy, striving to bring new hope to patients with diseases lacking effective treatment options.

SOURCE T-MAXIMUM PHARMACEUTICAL