ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies

Follicular Lymphoma Clinical Trial

Official title:

A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic CD20-conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653271
• Other study ID #: ACE1831-001
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• B-cell Lymphoma
• DLBCL
• Follicular Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Marginal Zone Lymphoma
• Non Hodgkin Lymphoma
• Primary Mediastinal Large B Cell Lymphoma

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