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ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Sponsor: Acepodia Biotech, Inc.
Summary
ACE2016 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR). The ACE2016-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, persistency, pharmacodynamics and efficacy of ACE2016 in patients with Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR).
Official title: A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE2016, an Allogeneic Anti-EGFR Conjugated Gamma Delta T Cell (gdT) Therapy in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-08-22
Completion Date
2027-03-27
Last Updated
2025-07-01
Healthy Volunteers
No
Interventions
Cyclophosphamide
Lymphodepleting agent
Fludarabine
Lymphodepleting agent
ACE2016
Allogeneic gamma delta T (gdT) cell therapy
Pembrolizumab
Immune checkpoint anti-PD-1 antibody
Locations (9)
University of California San Diego
San Diego, California, United States
SCRI Denver Drug Development Unit
Denver, Colorado, United States
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
Texas Oncology
Dallas, Texas, United States
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
Chang Gung Medical Foundation Linkou
Taoyuan, Guishan District, Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Zhonghe District, Taiwan
Mackay Memorial Hospital Taipei
Taipei, Zhongshan District, Taiwan
Taichung Veteran General Hospital
Taichung, Taiwan