ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL
About this trial
This is an interventional treatment trial for B-cell Lymphoma
Eligibility Criteria
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
Sites / Locations
- AdventHealth OrlandoRecruiting
- Emory UniversityRecruiting
- Norton Cancer InstituteRecruiting
- Hackensack University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Treatment Group A (ACE1831)
Treatment Group B (ACE1831 and obinutuzumab)
ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.
ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.