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

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

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 Overview

• Status: Recruiting
• Conditions: Follicular Lymphoma; B-cell Lymphoma; Burkitt Lymphoma; Marginal Zone Lymphoma; Non Hodgkin Lymphoma; DLBCL; High-grade B-cell Lymphoma; Primary Mediastinal Large B Cell Lymphoma
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: ACE1831; Drug: Obinutuzumab

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stephanie Chien; Phone Number: +1 415-366-7822; Email: clinical@acepodiabio.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Principal Investigator: Choi-Wan Eric Tse
• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • Kaohsiung Chang-Gung Memorial Hospital
    • Principal Investigator: Ming-Chung Wang
  • New Taipei City, Taiwan
    • Recruiting
    • Tamsui MacKay Memorial Hospital
    • Principal Investigator: Yu-Cheng Chang, MD
  • New Taipei City, Taiwan
    • Recruiting
    • Ministry of Health and Welfare Shuang-Ho Hospital
    • Principal Investigator: Yao-Yu Hseih
  • Taichung, Taiwan
    • Recruiting
    • Taichung Veterans General Hospital
    • Principal Investigator: Kuan-Der Lee
  • Tainan, Taiwan
    • Recruiting
    • National Cheng Kung University Hospital
    • Principal Investigator: Tsai-Yun Chen
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Principal Investigator: Shang-Ju Wu
  • Taoyuan City, Taiwan
    • Recruiting
    • Linkou Chang-Gung Memorial Hospital
    • Principal Investigator: Tung-Liang Lin, MD
• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Recruiting
      • AdventHealth Orlando
      • Principal Investigator: Rushang D Patel, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Principal Investigator: Amelia Langston, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Terminated
      • Indiana University Simon Comprehensive Cancer Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Recruiting
      • Norton Cancer Institute
      • Principal Investigator: Don A Stevens, MD
      • Contact: MD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Principal Investigator: Ranjit Nair, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 or subjects with ECOG scores of 2 with a serum albumin of >3.5
• 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 (however, subjects on anti-retroviral therapy for at least 4 weeks and with HIV viral loads of <400 copies/mL are eligible), 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group A (ACE1831); ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.	Drug: Cyclophosphamide; Lymphodepleting agent; Drug: Fludarabine; Lymphodepleting agent; Drug: ACE1831; Allogeneic gamma delta T (gdT) cell therapy
Experimental: Treatment Group B (ACE1831 and obinutuzumab); ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.	Drug: Cyclophosphamide; Lymphodepleting agent; Drug: Fludarabine; Lymphodepleting agent; Drug: ACE1831; Allogeneic gamma delta T (gdT) cell therapy; Drug: Obinutuzumab; Anti-CD20 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)		2 years
Change from baseline in ECOG status		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)	1 year
Change from baseline clinical laboratory tests results	Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)	1 year
Change from baseline in urinalysis results	Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)	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)	1 year
Change from baseline in electrocardiogram (ECG) results	Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)	1 month
Maximum Tolerated Dose (MTD)		1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence of ACE1831 after administration	Half-life of ACE1831	1 month
Measure of anti-ACE1831 antibodies after administration	Titration of anti-ACE1831 antibodies after administration	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	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics of ACE1831	Serum levels of interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10, as well as other potential biomarkers	2 years

Collaborators and Investigators

• Sponsor: Acepodia Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Infections; Virus Diseases; Neoplasms by Histologic Type; DNA Virus Infections; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Epstein-Barr Virus Infections; Herpesviridae Infections; Tumor Virus Infections; Lymphoma; Lymphoma, B-Cell; Burkitt Lymphoma; Lymphoma, B-Cell, Marginal Zone; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Fludarabine; Obinutuzumab
• Other Study ID Numbers: ACE1831-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No