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

August 6, 2025 updated by: Acepodia Biotech, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 2 years
2 years
Change from baseline in ECOG status
Time Frame: 1 year
1 year
Change from baseline in physical examination results
Time Frame: 1 year
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
Time Frame: 1 year
Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
1 year
Change from baseline in urinalysis results
Time Frame: 1 year
Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
1 year
Change from baseline in vital signs results
Time Frame: 1 year
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
Time Frame: 1 month
Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
1 month
Maximum Tolerated Dose (MTD)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Persistence of ACE1831 after administration
Time Frame: 1 month
Half-life of ACE1831
1 month
Measure of anti-ACE1831 antibodies after administration
Time Frame: 1 month
Titration of anti-ACE1831 antibodies after administration
1 month
Objective Response Rate (ORR)
Time Frame: 2 years
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacodynamics of ACE1831
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acepodia Biotech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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