A Phase 1/2 Study of MB-106 CAR T Cell Therapy in People with B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

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Full Title

A Phase 1/2, Open Label, Multicenter Study to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients with Relapsed or Refractory CD20+ B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia (Advarra)

Purpose

In this study, researchers are assessing the effectiveness of MB-106 in people with blood cancers. The people in this study have B-cell non-Hodgkin lymphoma (NHL), including Waldenstrom macroglobulinemia (WM) or chronic lymphocytic leukemia (CLL). Their cancers did not respond to treatment or came back afterward. The cancer cells have a protein on their surfaces called CD20.

MB-106 is a type of immunotherapy called CAR T cell therapy. The treatment involves removing some of your immune cells called T cells. The T cells are genetically changed so they recognize cancer cells containing CD20. They are multiplied in a laboratory. Then doctors return them to you to find and kill NHL or CLL cells in your body. 

If you join this study, you will first get two chemotherapy drugs called cyclophosphamide and fludarabine. These medications prepare your body for MB-106. The treatments in this study are given intravenously (by vein).

Who Can Join

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

  • Have B-cell NHL, WM, or CLL that keeps growing or came back after treatment.
  • Have CD20 on the cancer cells.
  • Have recovered from the serious side effects of previous treatments before getting MB-106.
  • 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. M. Lia Palomba’s office at 646-608-3711.

Protocol

23-300

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05360238