NCT05653271

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Acepodia Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-cell Lymphoma
• Non Hodgkin Lymphoma
• DLBCL
• Primary Mediastinal Large B Cell Lymphoma
• Marginal Zone Lymphoma
• Follicular Lymphoma
• Burkitt Lymphoma
• High-grade B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Lymphodepleting agent
DRUG	Fludarabine	Lymphodepleting agent
DRUG	ACE1831	Allogeneic gamma delta T (gdT) cell therapy
DRUG	Obinutuzumab	Anti-CD20 monoclonal antibody

Timeline

• Start date: 2023-01-21
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2022-12-16
• Last updated: 2025-08-11

Locations

13 sites across 3 countries: United States, Hong Kong, Taiwan

Regulatory

• FDA-regulated drug study