Phase I Study of Super1 TCR-T Cell Therapy in HLA-A*02 Positive Patients with NY-ESO-1 Positive Advanced Solid Tumors Aged 18 to 75

What this Trial Is About

Researchers are conducting a phase I clinical trial to evaluate the safety and tolerability of Super1 TCR-T cells in patients with advanced solid tumors who are positive for the NY-ESO-1 antigen. This open-label, single-center study involves a dose escalation design to assess treatment effects in patients with sarcoma, lung cancers, or melanoma who have experienced first-line treatment failure. The trial includes patients aged 18 to 75 years with measurable tumors and specific genetic markers. Participants receive a lymphoid-depleting preconditioning regimen before receiving an infusion of Super1 TCR-T cells, followed by seven days of interleukin administration. The treatment dose is escalated in a 33 design across three dose levels, with each participant receiving only one cell reinfusion. Prior to enrollment, patients undergo HLA genotype testing and tumor tissue immunohistochemistry to confirm eligibility based on HLA-A*02 status and NY-ESO-1 positivity. Throughout the study, participants undergo regular testing, evaluations, and management visits as scheduled by the research institution. Researchers monitor dose-limiting toxicities and maximum tolerated doses within 28 days after treatment. Longer-term outcomes such as overall response rate, overall survival, and progression-free survival are assessed up to one year after cell reinfusion. Safety and treatment effects are closely tracked during the trial period, which concludes in mid-2027.

An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors