A Phase 1 Study of AFNT-211 Cell Therapy in People With Solid Tumors


Full Title

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


Researchers want to find the best dose of a new cell therapy called AFNT-211 for people with solid tumors. The people in this study have solid tumors that have metastasized (spread) and keep growing even after treatment. In addition, their tumors have a mutation (change) in a gene called KRAS G12V. They also have HLA-A*11:01, a protein that your immune system can use to help recognize cancer cells.

AFNT-211 is made from your own white blood cells called T cells. Some types of cancer can block T cells from attacking cancer cells. If you join this study, we will collect some of your T cells and modify (change) them in a lab. The modified T cells are then returned to your body to detect and destroy cancer cells.

Before you get AFNT-211, you will get fludarabine and cyclophosphamide. These chemotherapy drugs will prepare your body to receive AFNT-211. These treatments are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have a metastatic solid tumor that keeps growing even after treatment and has a KRAS G12V mutation.
  • Have HLA-A*11:01.
  • Have recovered from the serious side effects of prior therapies before getting the study treatment.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.


For more information and to see if you can join this study, please call Dr. Adam Schoenfeld at 646-608-2091.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory




ClinicalTrials.gov ID