This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML). This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r 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
18
NK cell therapy
Lympho-conditioning Agent
Lympho-conditioning Agent
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGIncidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to approximately 2 years after last dose of QN-030a
Incidence of dose adjustment or discontinuation due to NK cell toxicities
Time frame: Up to approximately 2 years after last 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
Determine the Maximum tolerated dose (MTD) and RP2D
Time frame: 28 Days from first dose of QN-030a
Overall Response Rate(ORR) of QN-030a in r/r AML
Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator.
Time frame: Up to approximately 2 years after last dose of QN-030a
Relapse-free survival (RFS) of QN-030a in r/r AML
Time frame: Up to approximately 2 years after last dose of QN-030a
Time to Response (TTR) of QN-030a in r/r AML
Time frame: Up to approximately 2 years after last dose of QN-030a
Event-free survival (EFS) of QN-030a in r/r AML
Time frame: Up to approximately 2 years after last dose of QN-030a
Overall Survival (OS) of QN-030a in r/r AML
Time frame: Up to approximately 2 years after last dose of QN-030a
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Lympho-conditioning Agent
Lympho-conditioning Agent
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood
The 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
Evaluate the immunogenicity features of QN-030a
The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.
Time frame: Up to approximately 2 years after last dose of QN-030a