Phase I Study of Autologous p95HER2.CAR-TECH2Me T Cells in Patients with Advanced HER2-Positive Solid Tumors

The primary objective of this phase I study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of autologous p95HER2.CAR-TECH2Me T cells in patients diagnosed with advanced cancer exhibiting HER2 positivity. This investigation is clinically significant for determining the initial safety profile and biological behavior of this cellular therapy in patients with locally advanced, recurrent, or metastatic breast, gastric, or endometrial solid tumors. Secondary objectives include the assessment of preliminary anti-tumor activity.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients with locally advanced, recurrent, or metastatic breast, gastric, endometrial, or selected other solid tumors characterized by HER-2 positive expression (3+). The demographic profile includes both females and males within the age ranges of 3 and 4 years. This population is identified as vulnerable.

This Phase I, open-label, non-randomized, dose-escalation trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of autologous p95HER2.CAR-TECH2Me T cells. The study is conducted in patients diagnosed with locally advanced, recurrent, or metastatic breast cancer, gastric cancer, endometrial cancer, or other selected solid tumors exhibiting positive HER-2 expression (3+). The research methodology involves a systematic escalation of doses to monitor clinical responses and biological effects. The sequence of study procedures begins with a screening visit to determine eligibility. Subsequent follow-up visits are scheduled to assess clinical outcomes and physiological parameters, concluding with an end-of-study visit. Total participant involvement and the specific circumstances leading to early termination are not specified.

The clinical trial evaluates the efficacy in patients diagnosed with HER-2 positive solid tumors, including locally advanced, recurrent, or metastatic breast cancer, gastric cancer, and endometrial cancer.