Phase I Study of YK1101 Injection Using Engineered T Cells Targeting MAGE-A4 in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, efficacy, and pharmacokinetics of a new treatment called autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell TCR-T in patients with advanced solid tumors that express the MAGE-A4 protein. This early phase, open-label, single-arm study aims to find the right dose and observe initial effects in patients who have recurrent or metastatic solid tumors and have not responded well to standard treatments. The study involves administering YK1101 cells, which are TCR-T cells engineered to target MAGE-A4, along with preconditioning drugs fludarabine and cyclophosphamide. Participants will receive these treatments as part of a dose escalation to determine safety and optimal dosing. The study is designed to monitor treatment effects over time and includes measuring responses and survival outcomes for up to two years. Participants will undergo screening to confirm eligibility, including testing for MAGE-A4 expression and specific genetic markers. Throughout the study, they will be closely monitored for side effects, treatment response, and laboratory safety tests. Researchers will assess dose-limiting toxicities and adverse events within the first 28 days and continue to evaluate tumor response, progression-free survival, overall survival, and duration of response over the following two years. The total participation duration may extend to several years depending on follow-up.

Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors