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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06415487
Other study ID # ACE2016-001
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 31, 2024
Est. completion date March 25, 2027

Study information

Verified date May 2024
Source Acepodia Biotech, Inc.
Contact Stephanie Chien
Phone +1 415 366 7822
Email clinical@acepodiabio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 25, 2027
Est. primary completion date December 18, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
Cyclophosphamide
Lymphodepleting agent
Fludarabine
Lymphodepleting agent
ACE2016
Allogeneic gamma delta T (gdT) cell therapy
Pembrolizumab
Immune checkpoint anti-PD-1 antibody

Locations

Country Name City State
United States SCRI Denver Drug Development Unit Denver Colorado
United States Sarah Cannon Research Institute (SCRI) Oncology Partners Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Acepodia Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Pharmacodynamics of ACE2016 Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets. 1 year
Other gdT infiltration in tumor mass Optional biopsy to examine gdT cell infiltration 1 year
Primary 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 1 year
Primary Change from baseline in clinical laboratory tests results Number of subject with change from baseline clinical significant lab findings by cohort (descriptive) 1 year
Primary Change from baseline in vital signs results Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive) 1 year
Primary Recommended Dose (RD) 1 year
Secondary Persistence of ACE2016 before and after administration Half-life of ACE2016 1 year
Secondary Measure of anti-ACE2016 antibodies after administration Titration of anti-ACE2016 antibodies after administration 1 year
Secondary Objective Response Rate (ORR) Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1 1 year
Secondary Disease Control Rate (DCR) Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1 1 year
Secondary Duration Of Response (DOR) Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death. 1 year
Secondary Progression Free Survival (PFS) Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death 1 year
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