T MAXIMUM secures US FDA clearance for Phase 2 CAR T trial
Biotechnology firm T MAXIMUM received regulatory clearance from the US Food and Drug Administration to initiate a Phase 2 trial of MT027 for secondary brain metastases
BEIJING, Oct. 12, 2026 /PRNewswire/ -- T-MAXIMUM PHARMACEUTICAL (T-MAXIMUM) announced today that the U.S. Food and Drug Administration (FDA) has cleared the company to begin a Phase 2 clinical study of MT027, an allogeneic CAR-T therapy targeting B7-H3. This marks the second FDA-approved Phase 2 study for MT027, following its clearance for use in recurrent glioblastoma, and the company has received Orphan Drug Designation and Fast Track Designation for the therapy.
With two cleared Phase 2 programs, T-MAXIMUM has created a dual-indication portfolio for universal CAR-T therapy, targeting both primary and metastatic intracranial solid tumors. Brain metastases, which are common in patients with lung cancer, breast cancer, and other types of cancer, can lead to significant symptoms and impact treatment options.
Approximately 20% of cancer patients may develop brain metastases, with the proportion reaching 20% to 40% among those with advanced solid tumors.
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