Lentivirally Redirected CD123 Autologous T Cells in AML

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

December 6, 2018

Primary Completion Date

December 3, 2033

Study Completion Date

December 3, 2033

Conditions
Acute Myeloid Leukemia, in RelapseAcute Myeloid Leukemia, AdultAcute Myeloid Leukemia, Refractory
Interventions
BIOLOGICAL

CART123 cells; cyclophosphamide; fludarabine

"CART123 cells following lymphodepleting chemotherapy in patients with relapsed/refractory AML. Subjects will be treated with a split dosing approach of CART123 cells (10% Day 0; 30% Day 1; 60% Day 2) for Cohort 1a/1b or a single IV administration of CART123 cells for Cohort 2.~The total dose administered to each subject will be based on body weight obtained at the time of apheresis. Thus, the target total transduced dose, preceded by lymphodepleting chemotherapy, is 1-2x10\^6 CART123 cells/kg for Cohort 1a, 5x10\^6 CART123 cells/kg for Cohort 1b, or 2x10\^6 CART-123 cells/kg for Cohort 2. The protocol-specified minimum acceptable dose for infusion is 1x10\^5 CART123 cells/kg."

Trial Locations (1)

19104

University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

University of Pennsylvania

OTHER