The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 33 (CD33)-directed chimeric antigen receptor modified T cells (CART-33) infusions in patients with relapsed / refractory acute myeloid leukemia (AML).
The relapsed and/or refractory AML patients will receive infusions of allogeneic CART-33 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily idarubicin and cytarabine, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)
Affiliated Hospital of Academy of Military Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGOccurrence of study related adverse events
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria
Time frame: 1 year
Overall response rate of allogeneic CART-33
A response is defined as: (1) a morphologic complete remission (CR) or (2) a complete remission with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2015) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR
Time frame: up to 24 weeks
Disease-free survival
Time frame: up to 24 weeks
Overall survival
Time frame: up to 24 weeks
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