Full Title
A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AMpLify)Purpose
Researchers are doing this study to find the best dose of CB-012 to treat acute myeloid leukemia (AML). The people in this study have AML that keeps growing even after treatment. Or they have a small amount of cancer cells in the body remaining after treatment (minimal residual disease or MRD).
CB-012 is a form of cellular therapy. It is made using white blood cells (T cells) collected from a healthy donor. T cells are important protective cells of your immune system. The T cells in CB-012 have been genetically modified (changed) to recognize specific proteins on your leukemia cells. These genetically modified T cells are called chimeric antigen receptor (CAR) T cells.
Before you receive CB-012, you will get the anti-cancer drugs fludarabine and cyclophosphamide. These chemotherapy drugs briefly weaken your immune system and help prepare your body to receive CB-012.
Who Can Join
To join this study, there are a few conditions. You must:
- Have AML that came back or keeps growing after treatment, or have MRD.
- Be eligible for a stem cell transplant. This may be needed if your bone marrow is not making blood cells quickly enough.
- 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. Jae Park’s office at 646-608-2091.