Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

April 8, 2021

Primary Completion Date

May 19, 2023

Study Completion Date

May 19, 2023

Conditions
Acute Myeloid LeukemiaRelapse LeukemiaRefractory Acute Myeloid Leukemia
Interventions
BIOLOGICAL

chimeric antigen receptor T cell

Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m\^2( body surface area) and cyclophosphamide 250 mg/m\^2( body surface area) for 3 days. Then this study will be using the Bayesian optimal interval phase I/II (Boin12) trial design. The protocol preset 2 dose levels: Dose 1 (DL-1) was 5×10\^5 (±20%) CAR T cells/kg, and dose 2 (DL-2) was 1×10\^6 (±20%) CAR T cells/kg. If the above dose cannot be met, subjects can still enter the study upon investigator consideration but require documentation of dosing. The lowest dose is 1×10\^5 CAR T cells/kg (±20%), and the highest dose is 1×10\^6 CAR T cells/kg (±20%). If the dose is out of the range mentioned above, entry into the trial will not be considered.

Trial Locations (1)

100000

Beijing Boren Hospital, Beijing

All Listed Sponsors
lead

Beijing Boren Hospital

OTHER