This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Split intravenous infusion of CART-38 cells \[dose escalating infusion of (5-20)x10\^6 CART-38 cells/kg\].
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGNumber of Adverse Events
Adverse events are evaluated with CTCAE V5.0
Time frame: 12 months
Overall response rate (ORR)
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)：Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)：All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Time frame: 2 years
Event-free survival (EFS)
time from enrollment to the date of primary refractory disease, or relapse from CR or CRi, or death from any cause.
Time frame: 2 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse.
Time frame: 2 years
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