Full Title
A Phase 1/2 Study Investigating the Safety and Efficacy of Autologous TAC T Cells in Subjects with Unresectable, Locally Advanced or Metastatic Claudin 18.2+ Solid TumorsPurpose
Researchers are assessing a cellular therapy to treat solid tumors that have metastasized (spread) and keep growing after treatment. The therapy is called TAC01-CLDN18.2. The people in this study have solid tumors that make a protein called Claudin (CLDN) 18.2.
TAC01-CLDN18.2 is an immunotherapy made from your own white blood cells called T cells. If you join this study, we will collect some of your T cells. We will add a gene (a small piece of DNA) from a virus. This will help your T cells find and kill cancer cells that have the CLDN18.2 protein. These genetically changed T cells are called T-cell antigen coupler (TAC) T cells. Treatments made from them are called TAC T-cell therapies.
Before you get TAC01-CLDN18.2, you will get chemotherapy to briefly weaken your immune system. These drugs will help prepare your body to receive the TAC T-cell therapy. The treatments in this study are given intravenously (by vein).
The TAC T-cell therapy is given in the hospital. You must stay in the hospital for up to 7 days so we can monitor you for serious side effects. After you leave the hospital, you must stay within 1 hour of the hospital for the first full month.
You can receive up to 2 TAC01-CLDN18.2 treatments.
Who Can Join
To join this study, there are a few conditions. You must:
- Have a metastatic solid tumor that keeps growing after treatment and makes the CLDN 18.2 protein.
- Have recovered from the serious side effects of prior therapies before getting the study therapy.
- 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.
Contact
For more information or to see if you can join this study, please call Dr. Geoffrey Ku’s office at 646-608-2091.