Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by Sandip Patel, MD (ucsd)
Headshot of Sandip Patel
Sandip Patel

Description

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)

Keywords

Locally Advanced Solid Tumor, Metastatic Solid Tumor, Neoplasms, Cyclophosphamide, Pembrolizumab, Fludarabine, ACE2016

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego not yet accepting patients
    San Diego California 92093 United States
  • SCRI Denver Drug Development Unit accepting new patients
    Denver Colorado 80218 United States
  • Texas Oncology accepting new patients
    Dallas Texas 75246 United States

Lead Scientist at University of California Health

  • Sandip Patel, MD (ucsd)
    Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 68 research publications. Research interests: cancer immunotherapy · phase 1 clinical trials · cellular therapy · microbiome · thoracic oncology · NSCLC · immune related adverse events · spatial biology · cancer informatics · wearables and toxicity monitoring

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Acepodia Biotech, Inc.
ID
NCT06415487
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated