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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 treatmen…
Interventions
- DrugCyclophosphamide
Lymphodepleting agent
- DrugFludarabine
Lymphodepleting agent
- DrugACE1831
Allogeneic gamma delta T (gdT) cell therapy
- DrugObinutuzumab
Anti-CD20 monoclonal antibody
Locations (13)
- AdventHealth OrlandoOrlando, Florida
- Emory UniversityAtlanta, Georgia
- Indiana University Simon Comprehensive Cancer CenterIndianapolis, Indiana
- Norton Cancer InstituteLouisville, Kentucky
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Queen Mary HospitalHong Kong