A Phase I Study of CD19-Targeted CAR T-Cell Therapy to Treat Patients with Recurrent or Persistent B-Cell Leukemia or Lymphoma

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Full Title

A Phase I Study of CD19-Targeted 19(T2)28z1xx Chimeric Antigen Receptor (CAR) Modified T Cells in Adult Patients with Relapsed or Refractory B-cell Malignancies

Purpose

This study is evaluating the safety of a new form of CAR T-cell therapy for patients with B-cell leukemia or lymphoma that have 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 19(T2)28z1xx. The modified T cells recognize a protein on cancer cells called CD19 and have been further engineered from previous generations of CAR to improve their effectiveness and provide prolonged immunity against tumors. There are other forms of CAR T-cell therapy that recognize CD19, but it is thought that the CAR T cells used in this study will help to shrink or stabilize cancer more effectively for a longer period of time after treatment.

Before patients receive 19(T2)28z1xx 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 leukemia or lymphoma that came back or continued to grow despite treatment.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jae Park at 646-608-3743.

Protocol

20-167

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators