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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653271
Other study ID # ACE1831-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 21, 2023
Est. completion date September 2027

Study information

Verified date February 2024
Source Acepodia Biotech, Inc.
Contact Stephanie Chien
Phone +1 415-366-7822
Email clinical@acepodiabio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date September 2027
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines - At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - Adequate hematologic and renal, hepatic, and cardiac function - Oxygen saturation via pulse oxygenation = 92% at rest on room air Key Exclusion Criteria: - Prior treatment with a genetically modified cell therapy product targeting CD20 - Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation - History of central nervous system (CNS) lymphoma or primary CNS lymphoma - History or presence of clinically relevant CNS disorder (e.g. epilepsy) - Clinically significant active infection - Currently active, clinically significant cardiovascular disease - Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection - History of other malignancies with the exception of certain treated malignancies with no evidence of disease - Primary immunodeficiency disorder - Pregnant or lactating female - Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent

Study Design


Intervention

Drug:
Cyclophosphamide
Lymphodepleting agent
Fludarabine
Lymphodepleting agent
ACE1831
Allogeneic gamma delta T (gdT) cell therapy
Obinutuzumab
Anti-CD20 monoclonal antibody

Locations

Country Name City State
Taiwan Tamsui MacKay Memorial Hospital New Taipei City
Taiwan Linkou Chang-Gung Memorial Hospital Taoyuan City
United States Emory University Atlanta Georgia
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Indiana University Simon Comprehensive Cancer Center Indianapolis Indiana
United States Norton Cancer Institute Louisville Kentucky
United States AdventHealth Orlando Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Acepodia Biotech, Inc.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Pharmacodynamics of ACE1831 Serum levels of interferon-?, TNF-a, IL-2, IL-6, IL-8 and IL-10, as well as other potential biomarkers 2 years
Primary Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs) 2 years
Primary Change from baseline in ECOG status 1 year
Primary Change from baseline in physical examination results Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive) 1 year
Primary Change from baseline clinical laboratory tests results Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive) 1 year
Primary Change from baseline in urinalysis results Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive) 1 year
Primary Change from baseline in vital signs results Number of subjects with change from baseline clinical significant vital signs findings by dose level (descriptive) 1 year
Primary Change from baseline in electrocardiogram (ECG) results Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive) 1 month
Primary Maximum Tolerated Dose (MTD) 1 month
Secondary Persistence of ACE1831 after administration Half-life of ACE1831 1 month
Secondary Measure of anti-ACE1831 antibodies after administration Titration of anti-ACE1831 antibodies after administration 1 month
Secondary 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 2 years
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