Phase I Open-Label Trial to Test Safety and Early Effectiveness of Autologous p95HER2.CAR-TECH2Me T Cells in Adults with Advanced HER2-Positive Breast, Gastric, Endometrial, and Other Selected Cancers

What this Trial Is About

Researchers are investigating the safety, tolerability, and early anti-tumor effects of autologous p95HER2.CAR-TECH2Me T cells in adults with advanced HER2-positive cancers, including breast, gastric, endometrial, and other selected solid tumors. This phase I, open-label, non-randomized, dose-escalation trial also evaluates how the body processes and responds to these cells after intravenous administration. Participants will receive a non-myeloablative lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine on Days -4 to -2, followed by a single infusion of the p95HER2.CAR-TECH2Me cells on Day 0. Premedication is given before the cell infusion to prepare patients. The dosing of the investigational CAR-T cells varies based on the dose-escalation group assigned. Throughout the study, participants will be closely monitored for adverse events, laboratory abnormalities, vital signs, ECG changes, physical examination findings, and performance status up to three months post-infusion. Researchers will assess tumor response, progression-free survival, and overall survival for up to two years after treatment. The total study duration is approximately 60 months, including follow-up contacts from initial consent to final evaluation.

A Phase I Interventional Open-label, Non-randomized Dose-escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients With Selected Advanced Cancers.