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RECRUITING
NCT05653271
PHASE1

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

Sponsor: Acepodia Biotech, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Cyclophosphamide

Lymphodepleting agent

DRUG

Fludarabine

Lymphodepleting agent

DRUG

ACE1831

Allogeneic gamma delta T (gdT) cell therapy

DRUG

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