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 guidelinesAt least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant LymphomaEastern Cooperative Oncology Group (ECOG) Performance Status 0-1Adequate hematologic and renal, hepatic, and cardiac functionOxygen saturation via pulse oxygenation ≥ 92% at rest on room airKey Exclusion Criteria:Prior treatment with a genetically modified cell therapy product targeting CD20Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantationHistory of central nervous system (CNS) lymphoma or primary CNS lymphomaHistory or presence of clinically relevant CNS disorder (e.g. epilepsy)Clinically significant active infectionCurrently active, clinically significant cardiovascular diseaseHuman Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infectionHistory of other malignancies with the exception of certain treated malignancies with no evidence of diseasePrimary immunodeficiency disorderPregnant or lactating femaleAny 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