ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of CD20-expressing B-cell malignancies. The ACE1831-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ACE1831 in patients with CD20-expressing Non-Hodgkin lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Lymphodepleting agent
Lymphodepleting agent
Allogeneic gamma delta T (gdT) cell therapy
Anti-CD20 monoclonal antibody
AdventHealth Orlando
Orlando, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGIndiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
TERMINATEDNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGQueen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGKaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGMinistry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan
RECRUITINGTamsui MacKay Memorial Hospital
New Taipei City, Taiwan
RECRUITINGTaichung Veterans General Hospital
Taichung, Taiwan
RECRUITING...and 3 more locations
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Time frame: 2 years
Change from baseline in ECOG status
Time frame: 1 year
Change from baseline in physical examination results
Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive)
Time frame: 1 year
Change from baseline clinical laboratory tests results
Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
Time frame: 1 year
Change from baseline in urinalysis results
Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
Time frame: 1 year
Change from baseline in vital signs results
Number of subjects with change from baseline clinical significant vital signs findings by dose level (descriptive)
Time frame: 1 year
Change from baseline in electrocardiogram (ECG) results
Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
Time frame: 1 month
Maximum Tolerated Dose (MTD)
Time frame: 1 month
Persistence of ACE1831 after administration
Half-life of ACE1831
Time frame: 1 month
Measure of anti-ACE1831 antibodies after administration
Titration of anti-ACE1831 antibodies after administration
Time frame: 1 month
Objective Response Rate (ORR)
Objective response of each patient's underlying lymphoma, duration of response, and progression-free survival all based on the revised IWG Response Criteria for Malignant Lymphoma
Time frame: 2 years
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