A Phase 1b-2 Study of AZD0120 CAR T Cell Therapy in People With AL Amyloidosis

Full Title

A Phase 1b/2 Study of AZD0120 (also known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B cell Maturation Antigen in Participants with Relapsed or Refractory AL Amyloidosis

Purpose

The purpose of this study is to find the best dose of AZD0120 to treat AL amyloidosis. The people in this study have AL amyloidosis that came back or does not get better with treatment.

AZD0120 is a cellular therapy made from your own white blood cells called T cells. If you join this study, we will collect some of your T cells and modify (change) them in a lab. This modification will help your T cells find and kill abnormal plasma cells. These genetically changed T cells are called chimeric antigen receptor (CAR) T cells. AZD0120 is a CAR T cell therapy and is given intravenously (by vein).

To prepare your body for AZD0120, you will also get fludarabine and cyclophosphamide, which are chemotherapy drugs. After you get AZD0120, you will be in the hospital for at least 10 days. You will then need to stay within a 1-hour travel distance of Memorial Sloan Kettering for the next 18 days so we can check on you.

Who Can Join

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

  • Have AL amyloidosis that came back or is not getting better after treatment.
  • Have recovered from the serious side effects of prior treatments before getting AZD0120.
  • 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 about this study or to see if you can join, please call Dr. Heather Landau’s office at 646-608-3740.

Protocol

25-343

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07081646