← Back to Search

CAR T-cell Therapy

ACE1702 for Cancer

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 ≤ 1
Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses the body's own natural killer cells to target and destroy tumors. The goal is to find out if it is safe and effective, and what the best dose is.

Who is the study for?
This trial is for adults with advanced or metastatic solid tumors expressing HER2, who can't have surgery and have no other treatment options. They must be in good physical condition (ECOG ≤ 1), not pregnant, without serious uncontrolled disorders, autoimmune diseases, untreated brain metastases, multiple cancers, or significant heart disease.Check my eligibility
What is being tested?
The study tests ACE1702 (anti-HER2 oNK cells) against various HER2-expressing solid tumors like breast and gastric cancer. It's to check the safety of different doses of ACE1702 and see how well it works. Participants will also receive Fludarabine and Cyclophosphamide to prepare their bodies for ACE1702.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever or fatigue; infusion-related reactions; possible organ inflammation due to NK cell activity; and typical chemotherapy side effects from Fludarabine and Cyclophosphamide like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can carry out all my self-care but not work activities.
Select...
My advanced cancer cannot be surgically removed and I can't or won't use other approved treatments.
Select...
My cancer tests show HER2 protein presence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)
Phase Ib/II starting dose for ACE1702
Secondary outcome measures
Evaluate immune function after administering ACE1702
Quantify NK cell persistence after administering ACE1702
Other outcome measures
Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)
Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1

Trial Design

6Treatment groups
Experimental Treatment
Group I: ACE1702 Dose Level 5Experimental Treatment3 Interventions
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 5 Planned number of subjects: 3 to 6
Group II: ACE1702 Dose Level 4Experimental Treatment3 Interventions
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 4 Planned number of subjects: 3 to 6
Group III: ACE1702 Dose Level 3Experimental Treatment3 Interventions
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 3 Planned number of subjects: 3 to 6
Group IV: ACE1702 Dose Level 2Experimental Treatment3 Interventions
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 2 Planned number of subjects: 1 to 6
Group V: ACE1702 Dose Level 1Experimental Treatment3 Interventions
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above. Dose Level: 1 Planned number of subjects: 1 to 6
Group VI: ACE1702 Dose 6Experimental Treatment3 Interventions
Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above. Dose Level: 6 Planned number of subjects: 3 to 6
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Acepodia Biotech Inc.Lead Sponsor
Acepodia Biotech, Inc.Lead Sponsor
1 Previous Clinical Trials
42 Total Patients Enrolled
Michael Kurman, MDStudy DirectorAcepodia Biotech, Inc.
9 Previous Clinical Trials
429 Total Patients Enrolled

Media Library

ACE1702 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04319757 — Phase 1
Gastric Cancer Research Study Groups: ACE1702 Dose Level 2, ACE1702 Dose Level 4, ACE1702 Dose Level 3, ACE1702 Dose Level 5, ACE1702 Dose 6, ACE1702 Dose Level 1
Gastric Cancer Clinical Trial 2023: ACE1702 Highlights & Side Effects. Trial Name: NCT04319757 — Phase 1
ACE1702 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04319757 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risk factors should be taken into account when considering the use of ACE1702?

"As this is an early-stage clinical trial, there is limited data available regarding ACE1702's efficacy and safety. Thus, our team has rated its security at a 1 on the scale of 1 to 3."

Answered by AI

What maladies does ACE1702 commonly alleviate?

"ACE1702 can be utilised to treat multiple sclerosis, mixed-cell type lymphoma and myelocytic acute leukemia."

Answered by AI

Does this research endeavor seek additional participants?

"According to clinicaltrials.gov, this experiment is still enrolling volunteers; it was unveiled on May 19th 2020 and the latest update occurred June 22nd 2022."

Answered by AI

Are there any other studies that have explored the efficacy of ACE1702?

"Currently, 889 clinical studies are in progress for ACE1702. Of those trials, 161 are at the Phase 3 stage. While Philadelphia, Pennsylvania has the most active research sites with this medication, there exists a total of 28443 locations running these investigations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
2020. "ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04319757.
~1 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top