Trial Filter

BETA

An intelligent search tool for clinical trials

Sign In
Back|NCT05653271Recruiting
Official Title

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

Phase
Phase 1
Sponsor
Acepodia Biotech, Inc.
Enrollment
42
Timeline
Jan 2023 → Sep 2027
About This Study

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 Criteria

  • 1CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines
  • 2At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma
  • 3Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or subjects with ECOG scores of 2 with a serum albumin of \>3.5
  • 4Adequate hematologic and renal, hepatic, and cardiac function
  • 5Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air

Exclusion Criteria

  • 1Prior treatment with a genetically modified cell therapy product targeting CD20
  • 2Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation
  • 3History of central nervous system (CNS) lymphoma or primary CNS lymphoma
  • 4History or presence of clinically relevant CNS disorder (e.g. epilepsy)
  • 5Clinically significant active infection
  • 6Currently active, clinically significant cardiovascular disease
  • 7Human 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
  • 8History of other malignancies with the exception of certain treated malignancies with no evidence of disease
  • 9Primary immunodeficiency disorder
  • 10Pregnant or lactating female
  • 11Any 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

Locations

13 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Amelia Langston, MD

AdventHealth Orlando

Orlando, Florida 32804

Recruiting

Rushang D Patel, MD

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

Terminated
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →