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

NCT05653271 · Acepodia Biotech, Inc.
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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
About this study
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.
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 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 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 (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 * 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
Study design
Enrollment target: 42 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-01-21
Estimated completion: 2027-09
Last updated: 2025-08-11
Interventions
Drug: CyclophosphamideDrug: FludarabineDrug: ACE1831Drug: Obinutuzumab
Primary outcomes
  • Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs) (2 years)
  • Change from baseline in ECOG status (1 year)
  • Change from baseline in physical examination results (1 year)
Sponsor
Acepodia Biotech, Inc. · industry
Contacts & investigators
ContactStephanie Chien · contact · clinical@acepodiabio.com · +1 415-366-7822
All locations (13)
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Indiana University Simon Comprehensive Cancer CenterTerminated
Indianapolis, Indiana, United States
Norton Cancer InstituteRecruiting
Louisville, Kentucky, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
Kaohsiung Chang-Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Ministry of Health and Welfare Shuang-Ho HospitalRecruiting
New Taipei City, Taiwan
Tamsui MacKay Memorial HospitalRecruiting
New Taipei City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Linkou Chang-Gung Memorial HospitalRecruiting
Taoyuan, Taiwan