Treatment of advanced solid tumors using ACE2016 cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates ACE2016, an allogeneic gamma delta T cell therapy derived from healthy donors, for patients with locally advanced or metastatic solid tumors that express the epidermal growth factor receptor (EGFR). The study is an open-label, Phase I trial designed to evaluate the safety, tolerability, pharmacodynamics, and efficacy of ACE2016 in this patient population. Participants will receive ACE2016 along with other treatments such as cyclophosphamide, fludarabine, and pembrolizumab. The trial aims to determine how well this innovative therapy works in patients who have not responded to previous treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)
* At least one measurable lesion as defined by RECIST v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate hematologic and renal, hepatic and cardiac function
* Oxygen saturation via pulse oximeter ≥92% at rest on room air

Exclusion Criteria:

* Prior treatment with a genetically modified cell therapy product targeting EGFR
* History of allogeneic transplantation
* Subjects with active CNS metastases
* History or presence of clinically relevant Central Nervous System (CNS) disorder (e.g. epilepsy)
* Clinically significant active infection
* Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* History of malignancies with the exception of certain treated malignancies with no evidence of disease.
* Primary immunodeficiency disorder
* Pregnant or lactating female
* Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment or comply with study requirements, including understanding and rendering of informed consent

Where it's running

• University of California San Diego
  San Diego, California, United States Recruiting
• SCRI Denver Drug Development Unit
  Denver, Colorado, United States Recruiting
• Sarah Cannon Research Institute (SCRI) Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Texas Oncology
  Dallas, Texas, United States Recruiting
• Taipei Veterans General Hospital
  Taipei, Beitou District, Taiwan Not yet recruiting
• Chang Gung Medical Foundation Linkou
  Taoyuan City, Guishan District, Taiwan Not yet recruiting

Study contacts

• Study coordinator: Stephanie Chien
• Email: clinical@acepodiabio.com
• Phone: +1 415 366 7822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.