A Phase I Study of N-Acetylcysteine in People Receiving CAR T-Cell Therapy for Lymphoma

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Full Title

Phase I Study of N-Acetylcysteine to Optimize Metabolic Tumor Microenvironment in CD19 CAR T-cell Therapy in Lymphoma

Purpose

CAR T-cell therapy is a type of immunotherapy used to treat some people with lymphoma that has continued to grow despite prior treatment. The treatment involves using a patient’s own T cells (a type of white blood cell), genetically modifying them in the laboratory to recognize a protein on cancer cells, and multiplying them. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancerous cells throughout the body.

After the modified T cells are returned, however, they sometimes undergo changes that may make them less effective in multiplying and attacking cancer. Doctors believe that the drug N-acetylcysteine (N-AC) may help prevent or reverse some of these changes and allow CAR T cells to grow and divide in the body. This may be a more effective treatment for lymphoma.

In this study, researchers want to find the highest dose of N-AC that can be given safely in combination with CAR T-cell therapy in people with lymphoma. N-AC and CAR T-cell therapy are both given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have lymphoma and be planning to receive axicabtagene ciloleucel CAR T-cell therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Connie Batlevi at 646-608-3707.

Protocol

21-386

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators