Treatment of advanced solid tumors using ACE2016 cell therapy
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)
This study is testing a new cell therapy called ACE2016 to see if it can help people with advanced solid tumors that have not improved with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acepodia Biotech, Inc. Industry-sponsored |
| Locations | 9 sites (San Diego, California and 8 other locations) |
| Trial ID | NCT06415487 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy, including one targeted therapy.
Not a fit: Patients with active central nervous system metastases or those who have previously received genetically modified cell therapy targeting EGFR may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that have limited treatment alternatives.
How similar studies have performed: Other studies using gamma delta T cell therapies have shown promise, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Diego, California and 8 other locations
- 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)
- Taipei Medical University-Shuang Ho Hospital — New Taipei City, Zhonghe District, Taiwan (Not_yet_recruiting)
- Mackay Memorial Hospital Taipei — Taipei, Zhongshan District, Taiwan (Not_yet_recruiting)
- Taichung Veteran General Hospital — Taichung, Taiwan (Not_yet_recruiting)
Study contacts
- Study coordinator: Stephanie Chien
- Email: clinical@acepodiabio.com
- Phone: +1 415 366 7822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.