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RECRUITING
NCT06415487
PHASE1

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

Sponsor: Acepodia Biotech, Inc.

View on ClinicalTrials.gov

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

DRUG

Cyclophosphamide

Lymphodepleting agent

DRUG

Fludarabine

Lymphodepleting agent

DRUG

ACE2016

Allogeneic gamma delta T (gdT) cell therapy

DRUG

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