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Off-the-Shelf immune cells take on tough lymphoma

NCT ID NCT05653271

Disease control Sponsor: Acepodia Biotech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new treatment called ACE1831 for adults with B-cell lymphoma that has come back or not responded to at least two prior treatments. ACE1831 uses immune cells from healthy donors that are modified to target and kill cancer cells. The study aims to see if the treatment is safe and tolerable, and whether it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ACE1831 (a type of immune cell from healthy donors, combined with an antibody to target cancer cells)
What this could lead to
If this works, it could offer a new treatment option for people with B-cell lymphoma who have run out of standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 42 people, so it is mainly checking safety. The therapy may not work or could cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Jan 2023

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm B-cell non-Hodgkin lymphoma Burkitt lymphoma diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma Lymphoma, B-Cell, Marginal Zone marginal zone lymphoma non-Hodgkin lymphoma primary mediastinal large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell lymphoma Burkitt lymphoma DLBCL Follicular lymphoma High-grade B-cell lymphoma Marginal zone lymphoma Non-Hodgkin lymphoma Primary mediastinal large B-cell lymphoma

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Kaohsiung Chang-Gung Memorial Hospital

    Kaohsiung City, Kaohsiung, Taiwan

  • Linkou Chang-Gung Memorial Hospital

    Taoyuan City, Taiwan

  • Ministry of Health and Welfare Shuang-Ho Hospital

    New Taipei City, Taiwan, Taiwan

  • National Cheng Kung University Hospital

    Tainan, Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taipei, Taiwan

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Queen Mary Hospital

    Hong Kong, Hong Kong, Hong Kong

  • Taichung Veterans General Hospital

    Taichung, Taiwan, Taiwan

  • Tamsui MacKay Memorial Hospital

    New Taipei City, Taiwan

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.