A Phase I Study of CAR T Cells from a Donor to Treat Patients Receiving a Donated Stem Cell Transplant for B-Cell Leukemia or Lymphoma

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Full Title

A Phase I Trial Evaluating the Safety of Consolidative Infusions of CD19-Specific Chimeric Antigen Receptor (CAR) T Cells Following T-cell Depleted Allogeneic Transplantation for High Risk B-cell Malignancies

Purpose

CAR T-cell therapy is a type of immunotherapy. Normally during CAR T-cell therapy, a patient’s own T cells (a type of white blood cell) are removed and genetically modified in the laboratory to recognize a protein on their cancer cells. This study is assessing a different kind of CAR T-cell therapy in people with B-cell leukemia or lymphoma who are receiving a stem cell transplant from a donor.

T cells from the same donor are modified in a laboratory to recognize and attack cancer cells containing a protein called CD19. The modified T cells are then given to the patient after the stem cell transplant to reduce the chance that the cancer will come back. This treatment is 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 acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), or B-cell non-Hodgkin lymphoma (B-NHL) and be candidates for an allogeneic (donated) stem cell transplant.
  • Patients must have a matched related donor.
  • Patients’ cancer cells must contain the CD19 protein.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 18-60.

For more information about this study and to inquire about eligibility, please contact Dr. Melody Smith at 646-888-2155.

Protocol

17-331

Phase

I

Disease Status

Relapsed or Refractory