ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
Lympho-conditioning agent
Lympho-conditioning agent
Northwestern Univeristy
Chicago, Illinois, United States
MD Anderson Cancer Center
Houston, Texas, United States
Taipei Veteran General Hospital
Taipei, Taiwan
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
Number of subjects experiencing adverse events, and the frequency and severity of adverse events. Endpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD).
Time frame: Day 7 through Day 28 / Day 4 through Day 25
Phase Ib/II starting dose for ACE1702
The recommended phase Ib/II starting dose based on MTD. If MTD is not reached, then the recommended phase Ib/II dose will be determined based on the MAD, safety data, and pharmacodynamics data.
Time frame: Through study completion, up to 1 year
Quantify NK cell persistence after administering ACE1702
Duration of ACE1702 persistence
Time frame: Day 21
Evaluate immune function after administering ACE1702
Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints
Time frame: Day 21
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