A Phase II Study of Immunotherapy with Genetically Modified T Cells (JCAR015 Cells) to Treat Recurrent or Persistent B-Cell Acute Lymphoblastic Leukemia: The ROCKET Study

Full Title

The ROCKET Study: A Phase 2, Single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Purpose

The purpose of this study is to evaluate the safety and effectiveness of modified T cells to treat B-cell acute lymphoblastic leukemia (ALL) that has come back or continued to grow despite other treatments. The T cells are white blood cells that are removed from the patient and genetically modified in a laboratory to make them recognize a protein on B cells called CD19.

The modified T cells, called JCAR015 cells, are then returned intravenously (by vein) to the patient. The aim is for these altered immune cells to detect and kill leukemia cells. This approach is a form of immunotherapy.

Eligibility

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

  • Patients must have recurrent or persistent B-cell ALL that contains the CD19 protein.
  • Patients must have recovered from the serious side effects of prior therapies.
  • 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 212-639-4048.

Protocol

15-099

Phase

II

Investigator

Co-Investigators

Locations