Phase
Condition
Lymphoma, B-cell
Lymphoproliferative Disorders
Marginal Zone Lymphoma
Treatment
ACE1831
Fludarabine
Obinutuzumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- CD20-positive B-cell NHL that is persistent or progressive after having received atleast 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
Exclusion
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 ofallogeneic 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, orhepatitis C infection
- History of other malignancies with the exception of certain treated malignancies withno evidence of disease
- Primary immunodeficiency disorder
- Pregnant or lactating female
- Any medical, psychological, familial, or sociological conditions that, in the opinionof the Investigator or Sponsor Medical Monitor, would impair the ability of thesubject to receive study treatment, comply with study requirements, or understandingof the informed consent
Study Design
Connect with a study center
Tamsui MacKay Memorial Hospital
New Taipei City,
TaiwanActive - Recruiting
Linkou Chang-Gung Memorial Hospital
Taoyuan City,
TaiwanActive - Recruiting
AdventHealth Orlando
Orlando, Florida 32804
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Norton Cancer Institute
Louisville, Kentucky 40207
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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