Phase I Study of EPC-003 Anti-B7H3IL13Ra2 Armored CAR-T Cell Therapy for Adults with Recurrent or Refractory Glioblastoma

What this Trial Is About

Researchers are investigating the safety and effectiveness of EPC-003, a fully human bispecific armored Chimeric Antigen Receptor T-Cell Therapy CAR-T, in treating patients with recurrent or refractory glioblastoma. This Phase I, open-label study involves individuals whose glioblastoma has returned or not responded to standard treatments, focusing on those with tumors expressing specific markers B7H3 andor IL13Ra2. The trial aims to find the maximum tolerated dose and recommended dose for further studies while monitoring adverse effects. The trial is divided into two phases dose-escalation and dose-expansion. In the dose-escalation phase, four dose levels of EPC-003 CAR-T cells ranging from 2.5 to 20 million cells are administered weekly via intraventricular injection through an Ommaya reservoir, totaling six doses. Dose escalation follows a careful stepwise design to identify safe dosing limits. The dose-expansion phase enrolls six additional patients at the highest tolerable dose to confirm safety and optimal dosing. The infusion schedule may be adjusted based on patient response and safety. Participants undergo a screening period lasting about two weeks to confirm eligibility, including disease status and treatment history. During the study, they receive weekly cell infusions and are closely monitored for safety, including adverse events within 28 days after the first infusion. Researchers will assess tumor response, disease control, progression-free survival, and overall survival over a 12-month follow-up. The study involves laboratory tests, imaging, and clinical assessments to evaluate therapy effects and participant health throughout the trial, which may last up to one year or more.

B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma