Full Title
A First-in-Human, Open-Label Trial to Evaluate the Combination of ACTengineTM IMA203 with mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengineTM IMA203-102)Purpose
Researchers are seeking the best dose of mRNA-4203 to give with a cellular therapy in people with melanoma or sarcoma. The cellular therapy is called IMA203 and is custom-made from each patient’s white blood cells.
The people in this study have melanoma or synovial sarcoma that metastasized (spread) or is inoperable (cannot be surgically removed). In addition, their cancers have a protein called HLA-A*02:01.
IMA203 is made from T cells, which protect the body from infections, cancer, and other possible harms. Some cancers can block T cells from attacking cancer cells. We will collect some of your T cells and change them to help them find and kill your cancer cells. These modified T cells are called TCR (T cell receptor)-engineered T cells. Treatments made from them are called TCR T-cell therapies.
mRNA-4203 is a vaccine that may help activate the immune system to better target and kill cancer cells.
Who Can Join
To join this study, there are a few conditions. You must:
- Have HLA-A*02:01-positive metastatic or inoperable melanoma of the skin or synovial sarcoma.
- Have recovered from the serious side effects of previous treatments 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. James Smithy’s office at 646-888-6782.