A Phase II Study of Anakinra to Prevent or Treat Severe Side Effects in Patients Receiving CAR T-Cell Therapy for Leukemia or Lymphoma

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Full Title

A Phase II Study of IL-1 Receptor Antagonist Anakinra to Prevent Severe Neurotoxicity and Cytokine Release Syndrome in Patients Receiving CD19-Speciifc Chimeric Antigen Receptor (CAR) T Cells

Purpose

CAR T-cell treatment is a type of immunotherapy. The treatment involves using a patient’s own T cells (a type of white blood cell) and genetically modifying them in the laboratory to recognize a protein on cancer cells. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancerous cells throughout the body.

While this treatment has been shown to save lives, it can also cause side effects, such as affects on brain function and cytokine release syndrome (CRS). CRS results when high levels of inflammatory proteins are released in the body, causing fever, nausea, headache, a fast heart rate, and other serious problems.

Memorial Sloan Kettering Cancer Center researchers are conducting this study to see if the drug anakinra can prevent or reverse serious side effects related to CAR T-cell therapy in patients with recurrent leukemia or lymphoma. Anakinra is already approved by the U.S. Food and Drug Administration to treat rheumatoid arthritis and a rare inflammatory syndrome in newborns. It has anti-inflammatory properties and works by blocking a protein called interleukin-1, which is released into the blood during or shortly after CAR T-cell therapy.

Patients in this study will receive anakinra with CAR T-cell therapy. Anakinra is given by injection under the skin.

Eligibility

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

  • This study is for patients with recurrent B-cell acute lymphoblastic leukemia or non-Hodgkin lymphoma who will be receiving CAR T-cell therapy.
  • Patients must be age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 212-639-4048 or 212-639-5317.

Protocol

19-168

Phase

II

Investigator