A Phase I Study of CC-97540 CAR T-Cell Therapy in People with Relapsed or Persistent B-Cell Non-Hodgkin Lymphoma

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Full Title

A Phase 1, Multicenter, Open-Label Study of CC-97540, CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Purpose

This study is evaluating the safety of a new form of CAR T-cell therapy for patients with B-cell non-Hodgkin lymphoma (NHL) that has continued to grow or came back after prior treatment. With CAR T-cell therapy, some of a patient’s own T cells (a type of white blood cell) are removed and genetically modified in a laboratory to recognize their own cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancer cells throughout the body. This approach is a form of immunotherapy.

The CAR T-cell therapy being assessed in this study is called CC-97540. The modified T cells recognize a protein on cancer cells called CD19. There are other commercially available CD19 CAR T-cell therapies for people with recurrent or persistent B-cell NHL, and these therapies have been proven to be effective for shrinking or stabilizing cancer. However, due to the specific way the T cells in CC-97540 are manufactured, researchers think this treatment will help to shrink or stabilize cancer for a longer period of time than other CAR T-cell therapies.

Before patients receive CC-97540 CAR T cells, they will receive “conditioning” chemotherapy with fludarabine and cyclophosphamide to suppress the immune system and help prepare the body for receiving the CAR T cells. The treatments in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have B-cell NHL that came back or continued to grow after at least two regimens of therapy that included an anthracycline and rituximab (or other anti-CD20 treatment).
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. M. Lia Palomba at 646-608-3711.

Protocol

20-220

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators