This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML). The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
NK cell therapy
Lympho-conditioning Agent
Lympho-conditioning Agent
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 Days from first dose of QN-023a
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: 28 Days from first dose of QN-023a
Overall Response Rate(ORR)
Time frame: Up to approximately 2 years after last dose of QN-023a
Relapse-free survival (RFS) of participants
Time frame: Up to approximately 2 years after last dose of QN-023a
Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood
The PK of QN-023a in peripheral blood will be reported as the relative percentage of product (QN-023a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Time frame: Up to approximately 2 years after last dose of QN-023a
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Lympho-conditioning Agent