Phase 1 Study of Tumor-Associated Lymph Node T-Cell Injection for Adults With Advanced Malignant Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of tumor-associated lymph node T cell TAL-T therapy in patients with advanced malignant solid tumors, including melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer. This Phase I trial aims to explore dosage ranges and assess initial safety and possible effectiveness in patients who have failed standard treatments or have no effective options. Treatment involves removing at least one lymph node sample from each participant to isolate and expand TAL-T cells outside the body. Patients undergo lymphodepletion before receiving TAL-T cell infusions. Additionally, Serplulimab injections are given intravenously before and after TAL-T cell infusion. The study has two phases an exploration dose range phase with increasing doses to evaluate safety, followed by an expansion phase focusing on three preferred tumor types, with participant numbers adjusted based on earlier results. Participants will be monitored from the time they consent until 54 weeks after cell reinfusion for any adverse events or serious adverse events. Assessments include imaging to evaluate lesions, organ and bone marrow function tests, and questionnaires related to safety and treatment response. The trial measures outcomes such as objective response rate, disease control rate, duration of response, progression-free survival, and overall survival over two years, with safety data carefully collected throughout the study period.

A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors