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

Korábbi kezelés

• Prior treatment with a genetically modified cell therapy product targeting CD20

Más betegség

• 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
• 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

Egyéb

• Pregnant or lactating female

• 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