CAR-20/19-T Cells in Pediatric Patients With Relapsed/Refractory B Cell ALL
Condition(s)
Leukemia
Leukemia
Age Group
0-9 years 10-17 years 18-26 years 27 years and older
0-9 years 10-17 years 18-26 years 27 years and older
Phase(s)
1
1
Biological
CAR-20/19-T cells
Trial Summary & Details
Ages: 1 Year to 39 Years
Condition: Relapsed Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Pediatric Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia
Condition: Relapsed Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia With Failed Remission, Acute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Pediatric Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia
This is a phase 1, interventional, open label, treatment study designed to evaluate the safety and feasibility of infusion of CAR-20/19-T in pediatric and young adult subjects with B cell ALL that have relapsed after prior therapies or refractory disease and are not candidates for curative intent standard therapy. There will be two phases of this study. A dose escalation phase to determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a 6-patient dose expansion phase at the specified dose level.