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

Last updated: February 27, 2024
Sponsor: Acepodia Biotech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma, B-cell

Lymphoproliferative Disorders

Marginal Zone Lymphoma

Treatment

ACE1831

Fludarabine

Obinutuzumab

Clinical Study ID

NCT05653271
ACE1831-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • CD20-positive B-cell NHL that is persistent or progressive after having received atleast 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

Exclusion

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 ofallogeneic 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, orhepatitis C infection
  • History of other malignancies with the exception of certain treated malignancies withno evidence of disease
  • Primary immunodeficiency disorder
  • Pregnant or lactating female
  • Any medical, psychological, familial, or sociological conditions that, in the opinionof the Investigator or Sponsor Medical Monitor, would impair the ability of thesubject to receive study treatment, comply with study requirements, or understandingof the informed consent

Study Design

Total Participants: 42
Treatment Group(s): 4
Primary Treatment: ACE1831
Phase: 1
Study Start date:
January 21, 2023
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Tamsui MacKay Memorial Hospital

    New Taipei City,
    Taiwan

    Active - Recruiting

  • Linkou Chang-Gung Memorial Hospital

    Taoyuan City,
    Taiwan

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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