BEIJING, Dec. 21, 2025 — T-MAXIMUM Pharmaceutical has announced that its proprietary allogeneic CAR-T therapy targeting B7-H3, MT027, has obtained IND Clearance from the U.S. Food and Drug Administration (FDA) to launch a Phase II clinical trial for the treatment of recurrent glioblastoma (rGBM). This milestone represents a key breakthrough in addressing one of oncology’s most formidable challenges: developing effective allogeneic CAR-T therapies for solid tumors.
“The FDA’s IND clearance for MT027 is a robust validation of our strategic commitment to tackling the most challenging solid tumors,” stated Dr. Xiaoyun Shang, Founder and Chief Executive Officer of T-MAXIMUM Pharmaceutical. “This milestone is not just 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. MT027’s successful development and advancement are rooted in our deep immunology expertise and decisive investment in allogeneic cell-editing technologies. As a technology-driven company, T-MAXIMUM Pharmaceutical will continue to uphold a rigorous, pragmatic scientific approach, steadily advancing MT027’s clinical development. We remain dedicated to breaking new ground in the unexplored landscape of solid tumor cell therapy and using scientific power to gain more time for patients.”
About MT027
MT027 is an “off-the-shelf” allogeneic CAR-T product derived from healthy donors, engineered to target B7-H3 for recurrent glioblastoma treatment. As an allogeneic therapy, MT027 enables large-scale manufacturing and cryopreservation, allowing patients to receive treatment rapidly without delays linked to autologous cell production—an advantage critical for those facing fast-progressing, life-threatening diseases.
Unlike many industry peers relying on lentiviral or retroviral vectors, T-MAXIMUM Pharmaceutical has achieved a major advancement during MT027’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, marking the next generation of cell therapy engineering.
CAR-T therapies have revolutionized hematologic malignancy treatment; however, progress in solid tumors has been notably slower—especially in glioblastoma, where the blood-brain barrier, intratumoral heterogeneity, and immunosuppressive microenvironment pose unique challenges. FDA IND clearance for MT027’s Phase II clinical evaluation is 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 central nervous system cancers, often called 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 recurrent glioblastoma patients, treatment options are even more limited, with median survival typically less than 6–9 months. A profound unmet medical need persists in this area.
Since its founding, T-MAXIMUM Pharmaceutical has focused its R&D strategy on addressing these unmet needs, deliberately avoiding highly competitive hematologic indications to confront glioblastoma’s formidable challenge. 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 developing allogeneic, off-the-shelf cell therapies, with a mission to address diseases lacking effective treatments. The company has assembled 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 overcome key allogeneic cell therapy challenges—including graft-versus-host disease (GvHD) and immune rejection—enabling durable in-vivo persistence and therapeutic efficacy of CAR-T cells.
T-MAXIMUM currently focuses on late-stage malignant tumors; its lead recurrent glioma program 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 development.
Guided by integrity, innovation, and collaborative excellence, T-MAXIMUM Pharmaceutical remains committed to clinical value and original innovation. The company continues to pioneer solid tumor cell therapy breakthroughs, striving to bring new hope to patients with untreatable diseases.
SOURCE: T-MAXIMUM PHARMACEUTICAL