Evaluating Autologous CAR-T Cell Therapy Targeting CSPG4 in Relapsed or Refractory Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and tolerability of a new experimental treatment called autologous T lymphocyte chimeric antigen receptor cells targeting the CSPG4 antigen iC9.CAR-CSPG4 T cells in patients with head and neck cancer that has returned after standard therapy. The study aims to find the highest dose of these modified T cells that patients can safely receive without severe side effects. This phase 1 trial is sponsored by the UNC Lineberger Comprehensive Cancer Center. The study involves two parts first, blood is collected from participants to isolate and modify disease-fighting T cells to create the iC9.CAR-CSPG4 T cells. Then, participants receive a chemotherapy regimen called lymphodepletion using cyclophosphamide and fludarabine, followed by an infusion of the prepared iC9.CAR-CSPG4 T cells. The trial includes dose escalation to determine the maximum tolerated dose and recommended phase 2 dose. Participants will be closely monitored for side effects such as toxicity, cytokine release syndrome, and neurotoxicity during the first four weeks after treatment. The study team will also assess the recommended dose and participants response to therapy for up to two years. After treatment or if participants discontinue, follow-up will continue to collect safety and effectiveness information related to the gene transfer therapy.

Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC