A Phase I/II Study of KTE-C19 CAR T-Cell Immunotherapy for Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia

Full Title

KTE-C19-103: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

Purpose

With CAR T-cell therapy, a type of immunotherapy, white blood cells called T cells are removed from the patient, altered in the laboratory to recognize a protein on the patient’s cancer cells, multiplied to larger numbers, and returned to the patient to find and destroy cancer cells. It has been approved by the U.S. Food and Drug Administration to treat children and young adults with persistent or recurrent acute lymphoblastic leukemia (ALL) and some adults with a type of non-Hodgkin lymphoma.

In this study, researchers are assessing the safety and effectiveness of a type of CAR T-cell therapy for adults with recurrent or persistent ALL. The protein being targeted on the ALL cells is called CD19 and the treatment is called KTE-C19. The therapy is given intravenously (by vein). Before the infusion of KTE-C19 cells, patients will receive chemotherapy to reduce the number of leukemia cells and to allow KTE-C19 cells to live longer.

Eligibility

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

  • Patients must have B-precursor ALL that has come back or continued to grow despite standard therapy.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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. Jae Park at 212-639-5317.

Protocol

17-621

Phase

I/II

Investigator

Co-Investigators