This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in Acute Myeloid Leukemia Minimal Residual Disease(AML MRD). This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-020a in patients with AML MRD, 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
1
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-030a
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: 28 Days from first dose of QN-030a
Number of participants achieving MRD-
Time frame: 28 Days from first dose of QN-030a
Relapse-free survival (RFS) of participants
Time frame: Up to approximately 2 years after last dose of QN-030a
Overall survival (OS) of participants
Time frame: Up to approximately 2 years after last dose of QN-030a
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood
he PK of QN-030a in peripheral blood will be reported as the relative percentage of product (QN-030a) 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-030a
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lympho-conditioning Agent