Recruiting
Phase 1

ACE2016

Sponsor:

Acepodia Biotech, Inc.

Code:

NCT06415487

Conditions

Locally Advanced Solid Tumor

Metastatic Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Fludarabine

ACE2016

Pembrolizumab

Study Details

Brief 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).

Conditions

Locally Advanced Solid Tumor

Metastatic Solid Tumor

Study ID

NCT06415487

Start date

Aug 22, 2024

Status verified date

Jun, 2025

Completion date

Mar 27, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ACE2016 ONLY: 1 DOSE

ACE2016 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE2016.

experimental: ACE2016 ONLY: 3 DOSES

ACE2016 recommended dose, monotherapy. Lymphodepleting regimen followed by recommended dose of ACE2016.

experimental: ACE2016 AND PEMBROLIZUMAB: 3 DOSES

ACE2016 recommended dose, in combination with pembrolizumab. Lymphodepleting regimen followed by recommended dose of ACE2016, giving in combination with pembrolizumab.

Interventions

Cyclophosphamide

Lymphodepleting agent

Fludarabine

Lymphodepleting agent

ACE2016

Allogeneic gamma delta T (gdT) cell therapy

Pembrolizumab

Immune checkpoint anti-PD-1 antibody

Primary outcome measure

  • Incidence of DLTs, AESIs, Grade 3 or higher TEAEs, TEAEs considered related to ACE2016, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to treatment discontinuation will be summarized by cohort [ Time Frame: 1 year ]
  • Change from baseline in clinical laboratory tests results [ Time Frame: 1 year ]
  • Change from baseline in vital signs results [ Time Frame: 1 year ]
  • Recommended Dose (RD) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Stephanie Chien

+1 415 366 7822clinical@acepodiabio.com

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92093

Principal Investigator:

Sandip Patel, MD

SCRI Denver Drug Development Unit

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Jason Henry, MD

Sarah Cannon Research Institute (SCRI) Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Meredith Pelster, MD

Texas Oncology

Recruiting

Dallas, Texas, United States, 75246

Principal Investigator:

Scott Paulson, MD

More Information

Sponsor

Acepodia Biotech, Inc.

Last update posted

Jul 1, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Acepodia Biotech, Inc. on 2025-07-01.