Study of GK01 Autologous Tumor-Reactive T Cell Therapy in Adults With Advanced Solid Tumors Including Gastric, Esophageal, Cervical, Triple-Negative Breast, and Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of a new experimental treatment called GK01, which involves autologous tumor-reactive T cells, in patients with advanced solid tumors. This includes cancers such as advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. The study aims to explore how the treatment behaves in the body and its initial impact on tumors using RECIST 1.1 criteria. Patients will receive a specific dose of GK01 cells through cell transfusion according to a set protocol. The study uses a single-arm, open design where all participants receive the GK01 cell therapy. The treatment process involves culturing and preparing the patients own tumor-reactive T cells, which are then reinfused to target cancer cells. The study closely observes patients after transfusion for safety and tolerability, while also monitoring pharmacokinetic and pharmacodynamic profiles. Participants will be involved from enrollment through follow-up visits lasting at least 22 weeks. During this time, their health will be monitored through various assessments including blood tests, tumor measurements, and clinical evaluations to record safety outcomes and early signs of treatment efficacy. Researchers will also track the persistence and specificity of the infused cells. Overall, the study duration includes treatment and monitoring phases to evaluate both safety and initial therapeutic effects.

a Single-arm, Single-center, Open Clinical Study