Non Hodgkin Lymphoma Clinical Trial
ACE1831 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.
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
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, 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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There is 1 Location for this study
Louisville Kentucky, 40207, United States More Info
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