This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of iPSC NK cells in patients with relapsed/refractory AML or AML Minimal Residual Disease (MRD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 Days from first dose of iPSC NK cell infusion
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: 28 Days from first dose of iPSC NK cell infusion
Overall Response Rate(ORR)
Time frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
MRD negative rate
Time frame: 28 Days from first dose of iPSC NK cell infusion
Event-free survival
Time frame: Up to approximately 2 years after last dose of iPSC NK cell infusion]
Relapse-free survival
Time frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
Overall survival (OS)
Time frame: Up to approximately 2 years after last dose of iPSC NK cell infusion
Determination of the pharmacokinetics (PK) of iPSC NK cells in peripheral blood
The PK of iPSC NK in peripheral blood will be reported as the relative percentage of product 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 iPSC NK cell infusion
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Lympho-conditioning Agent
NK cell therapy
NK cell therapy