Pediatric Leukemia Adoptive Therapy (PLAT)-01: A Phase 1 Feasibility and Safety Study of Cellular Immunotherapy for Relapsed Pediatric CD19+ Acute Lymphoblastic Leukemia Using Autologous T-cells Lentivirally Transduced To Express a CD19-Specific Chimeric Antigen Receptor
Upon meeting the eligibility requirements and enrolling on study, subjects will undergo a
blood draw to obtain the T cells for the generation of the CD19 CAR+ T cells. The T cells
are isolated from the blood, transduced with a lentivirus to express the CD19 CAR, and
expanded in culture over a three week period. During the process of cell generation,
subjects will continue to be cared for by their primary oncologist and may undergo
additional treatment directed at the leukemia during this time.
After the CAR+ T cells have been generated, the subject undergoes a disease assessment and
will be admitted to the hospital to receive 2 days of cyclophosphamide for lymphodepletion
and reduction of disease burden. Several days later, the subject will receive an infusion
of the CAR+ T cells.
Following treatment with the CAR+ T cells, subjects will be intensely followed for 6 weeks
with serial blood testing and re-evaluation of disease status with bone marrow aspirates.
After 6 weeks, the subjects clinical care will be resumed by their primary oncologist, and
it is possible that they would receive additionally chemotherapy or a stem cell transplant.
Upon completion of the study, subjects will be followed at least annually with a either a
medical history, physical exam and blood tests or a phone call/questionnaire for 15 years.
This follow up will help to determine if the subject develops any long-term health problems
related to the CAR+ T cells including a new cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participant with Adverse Events
The safety of the T cell infusion will be described and the maximum tolerated dose determined.
Rebecca Gardner, MD
Seattle Children's Hospital
United States: Food and Drug Administration
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