FDA Clears T-MAXIMUM’s Allogeneic CAR-T Therapy MT027 for Phase II Glioblastoma Clinical Trials

BEIJING — December 21, 2025— T-MAXIMUM Pharmaceutical announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for MT027, a proprietary B7-H3-targeted allogeneic CAR-T therapy. This clearance allows the company to initiate a Phase II clinical trial for patients with recurrent glioblastoma (rGBM), a critical milestone in the effort to treat aggressive solid tumors with “off-the-shelf” cellular therapies.

A Non-Viral Leap in Cell Engineering

MT027 distinguishes itself from traditional CAR-T treatments by utilizing a fully non-viral gene-editing platform. While many industry competitors rely on lentiviral or retroviral vectors for gene delivery, T-MAXIMUM’s non-viral approach enhances product safety, improves manufacturing precision, and increases controllability. This next-generation engineering is essential for addressing glioblastoma—often called the “Mount Everest” of oncology due to the blood-brain barrier and a highly immunosuppressive microenvironment.

Solving the “Off-the-Shelf” Challenge

As an allogeneic therapy, MT027 is sourced from healthy donors rather than the patients themselves. This allows for:

• Large-Scale Manufacturing: Products can be mass-produced and cryopreserved.

• Rapid Treatment: Eliminates the weeks-long wait time associated with autologous (patient-derived) CAR-T production.

• Persistence and Safety: T-MAXIMUM’s proprietary platform overcomes Graft-versus-Host Disease (GvHD) and immune rejection, ensuring the CAR-T cells remain active within the patient’s body to fight the tumor.

Addressing Unmet Needs in Glioblastoma

Glioblastoma remains one of the most lethal central nervous system cancers, with a median survival rate of only 14–16 months. For recurrent cases, survival often drops to less than nine months. By targeting B7-H3—a protein highly expressed in solid tumors—MT027 aims to provide a powerful new option where the standard of care has historically failed.

“The FDA’s clearance represents a significant leap forward for the entire cell therapy field as we push into the ‘uncharted territory’ of solid tumor treatment,” said Dr. Xiaoyun Shang, Founder and CEO of T-MAXIMUM Pharmaceutical. “We remain committed to using the power of science to win more time for patients.”

T-MAXIMUM is concurrently leveraging its allogeneic technology to develop additional programs for brain metastases and other solid tumor indications, further expanding its clinical pipeline.