This federal Project Grant award from the National Cancer Institute (NCI), under the Cancer Treatment Research program (CFDA 93.395), provides $627,456 to the University of North Carolina at Chapel Hill (UNC-CH) to conduct a Phase I clinical trial evaluating a chimeric antigen receptor T-cell (CAR-T) therapy targeting the CSPG4 antigen in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The key objectives are to assess the safety and provide preliminary efficacy data for the CSPG4-targeted CAR-T cell therapy, as well as to characterize the immunological response and mechanisms of action. The study will enroll up to 12 patients in a modified 3+3 dose escalation design, with a dose expansion cohort at the recommended Phase II dose. Pre- and post-treatment tumor biopsies and serial blood samples will be collected to comprehensively evaluate the CAR-T cell phenotype, function, and impact on the broader T cell repertoire and tumor microenvironment. This research aims to advance the development of novel immunotherapies for this challenging cancer indication where treatment options are limited.
Mod # | Description | Reason For Modification | Federal Obligation (Click to sort descending) | Date (Click to sort ascending) |
|---|---|---|---|---|
| Not listed | $627.5k | 11/20/24 |