The purpose of this first-in-human study is to assess the safety, tolerability, antileukemic activity and maximum tolerated dose (MTD) of GDX012 in AML patients who are MRD positive by multiparametric flow cytometry. The study will consist of a dose escalation stage to evaluate various doses of GDX012 after a lymphodepletion regimen comprising fludarabine and cyclophosphamide. Following determination of the MTD of GDX012, the study will expand at the MTD. Patients will be followed up for 12 months, after receiving GDX012.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Biological: GDX012 Suspension for IV Infusion (single dose) following chemotherapy for lymphodepletion. Drug: Fludarabine; chemotherapy for lymphodepletion Drug: Cyclophosphamide; chemotherapy for lymphodepletion
City of Hope
Duarte, California, United States
Incidence of treatment emergent adverse events (AEs) and serious adverse events (SAEs)
AEs and SAEs occurring following administration of GDX012
Time frame: Up to 100 days
Incidence of treatment emergent clinically significant abnormal laboratory assessments
Standard clinical laboratory assessments for organ function (i.e. heart, kidney, liver)
Time frame: Up to 100 days
Incidence of dose limiting toxicities (DLTs)
DLTs occurring following administration of GDX012, measured using CTCAE 5.0 criteria
Time frame: Up to 100 days
Establish the maximum tolerated dose (MTD) of GDX012
Time frame: Up to 100 days
Evaluate the antileukemic activity of GDX012
Minimal residual disease (MRD) assessed by flow cytometry
Time frame: Up to 1 year
Evaluate the antileukemic activity of GDX012
Incidence of patients converting from MRD positive to MRD negative
Time frame: Up to 1 year
Evaluate the antileukemic activity of GDX012
Progression-free survival (PFS) and overall survival (OS)
Time frame: Up to 1 year
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