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

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

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

Allogeneic gamma delta T (gdT) cell therapy

ACE2016

Stephanie Chien

James Vick

Jason Henry, MD

Emily Lay Petcu

Meredith Pelster, MD

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).

ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

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)

Change from baseline IL2,6,8,10 IFN TNF, and change in TBNK cell subsets.

Optional biopsy to examine gdT cell infiltration

Number of subject with change from baseline clinical significant lab findings by cohort (descriptive)

Number of subjects with change from baseline clinical significant vital signs findings by cohort (descriptive)

Titration of anti-ACE2016 antibodies after administration

Proportion of subjects assessed as having a complete response (CR) or partial response (PR) according to RECIST v1.1

Number of subjects with a complete response (CR), partial response (PR) or stable disease (SD) as defined by RECIST v1.1

Duration (time) from the first tumor assessment showing response per RECIST v1.1 to the time of disease progression or death.

Duration (time) from first ACE2016 cell infusion to first documentation of disease progression per RECIST v1.1 or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)	NCT06415487	Locally Advance... Metastatic Soli...	Cyclophosphamid... Fludarabine ACE2016 Pembrolizumab	18 Years -	Acepodia Biotech, Inc.
ACE2016 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors Expressing Epidermal Growth Factor Receptor (EGFR)	NCT06415487	Locally Advance... Metastatic Soli...	Cyclophosphamid... Fludarabine ACE2016 Pembrolizumab	18 Years -	Acepodia Biotech, Inc.

Spots Global Cancer Trial Database for ace2016

Every month we try and update this database with for ace2016 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ace2016

Every month we try and update this database with for ace2016 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ace2016 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.