Full TitleA Phase I Dose Escalation Trial Using In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-Cell Malignancies
Normal T cells are white blood cells that fight infection and may also kill cancer cells. In this study, pediatric patients with acute lymphoblastic leukemia (ALL) that has persisted or returned after receiving a blood stem cell transplant from a donor will receive T cells from the same donor which have been genetically modified in the laboratory to recognize ALL cells that express the CD19 protein on their surfaces. The goal of the study is to determine a safe dose of these modified T cells that can be given to patients with relapsed ALL after transplantation. At the same time, patients’ response to treatment will be evaluated.
The T cells from each patient’s donor are grown in the lab. Researchers then insert a gene into the T cells that produces a protein to help the T cells recognize the patient’s CD19-positive ALL cells. Laboratory studies have shown that T cells modified in this way could kill some B cell cancers in mice.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CD19-positive ALL that persists or has returned after receiving a donated stem cell transplant.
- Patients’ donors must be willing make blood donations (from which T cells will be made).
- Patients must have been diagnosed with ALL before age 19.