Cyclophosphamide
DrugLymphodepleting agent
NCT Number: NCT06415487
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Taipei Veterans General Hospital, Taipei, Beitou District, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lymphodepleting agent
Lymphodepleting agent
Allogeneic gamma delta T (gdT) cell therapy
Immune checkpoint anti-PD-1 antibody
Time frame: 1 year
Time frame: 1 year
Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Time frame: 1 year
Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Time frame: 1 year
Time frame: 1 year
Half-life of ACE2016
Time frame: 1 year
Titration of anti-ACE2016 antibodies after administration
Time frame: 1 year
Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1
Time frame: 1 year
Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1
Time frame: 1 year
Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.
Time frame: 1 year
Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death
Time frame: 1 year
Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets.
Time frame: 1 year
Optional biopsy to examine gdT cell infiltration
Contact information is provided by the study sponsor or research team.
Acepodia Biotech, Inc.
Industry
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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