Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects with Advanced or Metastatic Solid Tumors

Brief description of study

This is study is testing a new medicine called AFNT-211 for patients with advanced or metastatic (cancer that has spread) that has specific genetic markers, known as HLA-A*11:01-positive and KRAS G12V-positive. The study has two parts: one to find the right amount of medicine that has few side effects, and another to see how well the treatment works in treating the cancer. Patients who had previous cancer treatment and specific genetic markers will join the study at different places. The study team will watch them for up to 24 months after patients get the first dose of AFNT-211, and then follow them for up to 15 years. There are three parts to the study: before treatment, during treatment, and after treatment. The goal is to figure out the best amount of the medicine that is effective in treating the cancer and make sure it has few side effects. The study also has a group that looks at the data regularly to make sure everything is going well for patients with the treatment. The study will continue until all patients finish, or if needed,move the patients to another follow-up plan.


Clinical Study Identifier: s23-01470
ClinicalTrials.gov Identifier: NCT06105021
Principal Investigator: Salman Rafi Punekar.
Other Investigators: Jaime Andres Suarez Londono, Nicole Karich, Elaine Shum, Rena Kandinova, Scot Niglio, Jamie M Pavlonnis, Eneil De La Pena, Marissa Hornacek, Kirby Rodriguez, Rafael C Singson, Amanda Marie Ferris, Oscar B Lahoud, Jingmei Hsu, Joshua K Sabari, Anna C Hatzinikolaou, Nina Beri, David R. Wise, Eileen Zhao, Julia M Buchheit, Jessica Wang, Mohammad Maher Abdul Hay, Maureen E Musatto, Kelsey Stocker, Sejal Singh, Laura P. Diaz, Samantha VanMaanen, Keriann M Scavone, Kristen Randolph Jordan, Jamie Robin Nemrow, Kristen Spencer, Chelsea F Curione, Kathleen M Madden, Nancy Chan, Taylor Patricia Harrington, Douglas K Marks.


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