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ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
Sponsor: Acepodia Biotech, Inc.
Summary
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.
Official title: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic Anti-CD20 Antibody-Conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2023-01-21
Completion Date
2027-09
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
Cyclophosphamide
Lymphodepleting agent
Fludarabine
Lymphodepleting agent
ACE1831
Allogeneic gamma delta T (gdT) cell therapy
Obinutuzumab
Anti-CD20 monoclonal antibody
Locations (13)
AdventHealth Orlando
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Queen Mary Hospital
Hong Kong, Hong Kong
Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City, Taiwan
Tamsui MacKay Memorial Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Linkou Chang-Gung Memorial Hospital
Taoyuan, Taiwan