A Phase 1b Study of NXC-201 Cellular Therapy for People With AL Amyloidosis

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Full Title

Phase 1b Dose Expansion Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis

Purpose

The purpose of this study is to find the best dose of NXC-201 to treat AL amyloidosis. The people in this study have AL amyloidosis that came back or does not get better with treatment.

NXC-201 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. NXC-201 is a CAR T cell therapy and is given intravenously (by vein).

To prepare your body for NXC-201, you will also get fludarabine and cyclophosphamide, which are chemotherapy drugs. After you get NXC-201, you will be in the hospital for at least 10 days. You will then need to stay within a 2-hour travel distance of Memorial Sloan Kettering for the next 4 weeks 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 NXC-201.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Heather Landau’s office at 646-608-3740.

Protocol

24-159

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06097832