PiggyBac-engineered membrane-bound IL-7 TILs combined with anti-PD-1 antibody demonstrates efficacy in recurrent ovarian cancer: a first-in-human phase 1 trial (TCR and WES)

This first-in-human phase 1 trial demonstrates that GC203, a piggyBac-engineered TIL product expressing membrane-bound IL-7 (mbIL-7), is feasible, safe, and clinically active in heavily pretreated recurrent ovarian cancer (rOC). GC203 regimen achieved a 33.3% objective response rate (ORR) and 83.3% disease control rate (DCR), with a median overall survival (mOS) of 17.1 months. Mechanistically, mbIL-7 enhanced T-cell persistence. The morisita overlap index (MOI) emerged as a predictive marker for response, enabling patient stratification. These findings support the continued development of cytokine-engineered TILs as a viable strategy to overcome immune barriers in refractory solid tumors, potentially expanding the application of adoptive cell therapy beyond currently approved indications. The dataset is TCR and WES profiling performed in the article.