A PHASE 1/2 MULTI-CENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF KTE-X19 IN PEDIATRIC AND ADOLESCENT SUBJECTS WITH RELAPSED/REFRACTORY B-PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA OR RELAPSED/REFRACTORY B-CELL NON-HODGKIN LYMPHOMA (ZUMA 4)
Kite Pharma, Inc., a for-profit biotechnology company, is funding this research study and has designed the trial. The sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s own genetically altered blood cells to treat cancer. KTE-C19 is made from blood cells that are removed from the patient. A virus (retrovirus) is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells, a type of blood cell that fights infection and eliminates cancer cells. The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after your child receives 3 days of chemotherapy, is safe and effective in treating your child’s leukemia.
Are you Eligible? (Inclusion Criteria)
- Relapsed or refractory B-precursor ALL in children and adolescents 2-21 years old.
- Adequate kidney, liver, lung and heart function.
- No central nervous system abnormalities.
- No uncontrolled infections, or infections requiring intravenous antimicrobials for management.
- Individuals of both genders of child bearing potential must be willing to practice birth control from the time of consent until 6 months after the completion of KTE-C19 treatment.