FDA Grants Fast Track Designation to MT027 for Recurrent Glioblastoma

The FDA has granted fast track designation to MT027, a B7-H3–targeted allogeneic CAR T-cell therapy, for the treatment of patients with recurrent glioblastoma.¹

MT027 is an off-the-shelf allogeneic CAR T-cell product that targets B7-H3 and is administered through a locoregional intracavitary route directed at intracranial tumors.

MT027 had previously received FDA orphan drug designation for recurrent high-grade glioma. The ongoing phase 2 GLIOMAX-101 trial (NCT07386002) is evaluating MT027 in patients with recurrent or progressive IDH wild-type glioblastoma who previously received standard-of-care therapy.²

“Receiving fast track designation from the FDA is an important milestone in the global development of MT027, but it is not the destination,” Xiaoyun Shang, chief executive officer of T-MAXIMUM Pharmaceutical, stated in a news release.¹ "What matters more to us is the continued validation — in the demanding setting of recurrent glioblastoma — of how target selection, an allogeneic off-the-shelf product, local delivery and clinical execution work together. Every piece of solid clinical evidence helps us refine the ongoing development of MT027 and provides translational experience that can inform our next-generation products and other intracranial solid tumor settings suited to local delivery. Going forward, T-MAXIMUM will continue to be guided by patient needs, and to advance allogeneic CAR-T in solid tumors on a foundation of safety, rigor and verifiable evidence."

What is the mechanism of action of MT027?

MT027 is an allogeneic CAR T-cell therapy engineered to target B7-H3, a transmembrane protein that is overexpressed across a range of solid tumors, including gliomas, while showing limited expression on most normal tissue.¹ According to T-MAXIMUM, the therapy is differentiated by the combination of B7-H3 targeting, its allogeneic format, and a locoregional intracavitary route of administration intended to deliver the cells directly to intracranial tumors.¹

How is the phase 2 GLIOMAX-101 study designed?

The open-label, multicenter phase 2 GLIOMAX-101 study is evaluating MT027 in patients with recurrent or progressive IDH wild-type glioblastoma that is WHO grade 4, and is designed to enroll approximately 40 patients.² Eligible patients need to be 18 to 70 years of age, must have received prior standard-of-care therapy and must have B7-H3–positive disease, defined as at least 20% of tumor cells staining at 2+ or 3+ intensity. A Karnofsky performance status of at least 60 and adequate organ function are also required. Patients with brainstem or thalamic recurrence, spinal cord dissemination, a single tumor larger than 5 cm or multiple tumors totaling more than 6 cm, uncontrolled intracranial hypertension, or prior CAR T-cell therapy or allogeneic transplantation are excluded.

MT027 is administered as an intracerebroventricular injection of 3 × 10⁷ cells on days 1 and 15 of each 28-day cycle. The trial includes a safety run-in of three to six patients evaluated for dose-limiting toxicities over 28 days, followed by a dose-expansion portion that enrolls additional patients for a total of approximately 40.

The primary end points are the incidence of dose-limiting toxicities during the safety run-in and the 12-month overall survival rate. The study is not yet recruiting.

References

1. T-MAXIMUM B7-H3-targeted allogeneic CAR-T therapy MT027 receives FDA fast track designation, accelerating global development for intracranial solid tumors. News release. T-MAXIMUM Pharmaceutical. August 31, 2026. Accessed September 1, 2026. https://finance.yahoo.com/healthcare/articles/t-maximum-b7-h3-targeted-120000170.html
2. The GLIOMAX study: MT027 allogeneic CAR-T for recurrent glioma (NCT07386002). ClinicalTrials.gov. Updated August 2026. Accessed September 1, 2026. https://clinicaltrials.gov/study/NCT07386002