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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Lymphodepleting agent
Lymphodepleting agent
Allogeneic gamma delta T (gdT) cell therapy
Immune checkpoint anti-PD-1 antibody
University of California San Diego
San Diego, California, United States
RECRUITINGSCRI Denver Drug Development Unit
Denver, Colorado, United States
RECRUITINGSarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, United States
RECRUITINGTexas Oncology
Dallas, Texas, United States
RECRUITINGTaipei Veterans General Hospital
Taipei, Beitou District, Taiwan
NOT_YET_RECRUITINGChang Gung Medical Foundation Linkou
Taoyuan City, Guishan District, Taiwan
NOT_YET_RECRUITINGTaipei Medical University-Shuang Ho Hospital
New Taipei City, Zhonghe District, Taiwan
NOT_YET_RECRUITINGMackay Memorial Hospital Taipei
Taipei, Zhongshan District, Taiwan
NOT_YET_RECRUITINGTaichung Veteran General Hospital
Taichung, Taiwan
NOT_YET_RECRUITINGIncidence 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
Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)
Time frame: 1 year
Change from baseline in vital signs results
Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)
Time frame: 1 year
Recommended Dose (RD)
Time frame: 1 year
Persistence of ACE2016 before and after administration
Half-life of ACE2016
Time frame: 1 year
Measure of anti-ACE2016 antibodies after administration
Titration of anti-ACE2016 antibodies after administration
Time frame: 1 year
Objective Response Rate (ORR)
Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1
Time frame: 1 year
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
Time frame: 1 year
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.
Time frame: 1 year
Progression Free Survival (PFS)
Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death
Time frame: 1 year
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