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CAR T-cell Therapy

ACE2016 for Metastatic Tumors

Phase 1

Recruiting

Research Sponsored by Acepodia Biotech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Locally advanced unresectable or metastatic solid tumors that have failed at least two lines of therapy (one of which must be targeted therapy)

Must not have

Human Immunodeficiency Virus (HIV) infection, active hepatitis B infection, or hepatitis C infection

Prior treatment with a genetically modified cell therapy product targeting EGFR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cell therapy called ACE2016, which comes from healthy donors and is being studied as a potential treatment for advanced or metastatic solid tumors that have a specific protein called Ep

Who is the study for?

This trial is for adults with advanced or widespread solid tumors that have a protein called EGFR. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not listed.

What is being tested?

The study tests ACE2016, an experimental cell therapy from healthy donors, alongside Fludarabine and Cyclophosphamide drugs, with or without Pembrolizumab. It's the first time this combination is being tried in humans to see if it's safe and works against these tumors.

What are the potential side effects?

Potential side effects aren't detailed here but may include typical reactions to immune therapies such as flu-like symptoms, fatigue, allergic reactions, and possibly organ inflammation due to immune system activation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced, cannot be surgically removed, and has not responded to at least two treatments, including one targeted therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV, active hepatitis B, or hepatitis C.

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I have been treated with a gene therapy targeting EGFR.

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I have had a transplant from another person.

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I currently have a serious infection.

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I have a significant brain disorder like epilepsy.

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I have active brain metastases.

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I have a primary immunodeficiency disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in clinical laboratory tests results

Change from baseline in vital signs results

Secondary study objectives

Disease Control Rate (DCR)

Duration Of Response (DOR)

Measure of anti-ACE2016 antibodies after administration

+3 more

Other study objectives

Pharmacodynamics of ACE2016

gdT infiltration in tumor mass

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: ACE2016 ONLY: 3 DOSESExperimental Treatment3 Interventions

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

Group II: ACE2016 ONLY: 1 DOSEExperimental Treatment3 Interventions

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

Group III: ACE2016 AND PEMBROLIZUMAB: 3 DOSESExperimental Treatment4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1830