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CAR T-cell Therapy
ET140203 T Cells for Pediatric Liver Cancer (ARYA-2 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Eureka Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease reoccurrence after remission following initial standard-of-care (SOC) treatment (i.e. relapse) or failure of response to SOC treatment (i.e. refractory).
Age ≥ 1 year and ≤ 21 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
ARYA-2 Trial Summary
This trial is testing a new treatment for cancer in children. The goal is to find out if it is safe and how well it works.
Who is the study for?
This trial is for pediatric patients aged 1-21 with relapsed/refractory liver cancers (HB, HCN-NOS, or HCC) who are AFP-positive/HLA-A2-positive. They should have a life expectancy over 4 months and good performance status. Patients must not have had recent cancer treatments or other investigational therapies and should not be on systemic immunosuppressants.Check my eligibility
What is being tested?
The trial tests ET140203 T-cells in children with specific liver cancers to find the safest dose that works best (Phase I/II). It's an open-label study where all participants receive the treatment, starting at lower doses which increase gradually to determine the optimal dose.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar cell therapies can cause immune reactions, flu-like symptoms, organ inflammation, and changes in blood counts. The severity of these side effects varies from mild to potentially serious.
ARYA-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease came back after initial treatment or didn't respond to it.
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I am between 1 and 21 years old.
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My liver cancer has been confirmed and my blood test shows AFP levels over 200ng/ml.
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I carry the HLA-A2 gene.
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My liver function is relatively good.
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I carry the HLA-A2 gene.
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I am mostly active and can care for myself.
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My liver function is fairly good.
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My liver cancer has been confirmed and my blood test shows AFP levels over 200ng/ml.
Select...
My disease came back or didn't respond after standard treatment.
Select...
I am between 1 and 21 years old.
Select...
I am mostly active and can care for myself.
ARYA-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence rates of adverse events (AEs) after infusion of ET140203 T cells
Incidence rates of dose limiting toxicities (DLTs) after infusion of ET140203 T cells
Severity rates of adverse events (AEs) after infusion of ET140203 T cells
+1 moreSecondary outcome measures
Assess the efficacy of ET140203 T cells in pediatric subjects with relapsed/refractory HB, HCN-NOS, or HCC
Determine the pharmacokinetics of ET140203 T cells after infusion.
ARYA-2 Trial Design
1Treatment groups
Experimental Treatment
Group I: ET140203 T CellsExperimental Treatment1 Intervention
ET140203 Autologous T Cells
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Who is running the clinical trial?
Eureka Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
145 Total Patients Enrolled
5 Trials studying Liver Cancer
50 Patients Enrolled for Liver Cancer
Pei Wang, PhDStudy DirectorEureka Therapeutics Inc.
3 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Liver Cancer
6 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My disease came back after initial treatment or didn't respond to it.I am on medication to suppress my immune system due to an autoimmune disease.My organs are working well.I cannot take certain chemotherapy drugs like Fludarabine and Cyclophosphamide.I am between 1 and 21 years old.I haven't had certain cancer treatments or steroids in the last 2 weeks.My liver cancer has been confirmed and my blood test shows AFP levels over 200ng/ml.I carry the HLA-A2 gene.My liver function is relatively good.I carry the HLA-A2 gene.I am mostly active and can care for myself.I have at least one tumor larger than 5mm or two tumors larger than 3mm.My liver function is fairly good.My organs are working well.My blood flow in major liver veins is blocked, making me unsuitable for the study.I have had an organ transplant.More than half of my liver is affected by cancer.My liver cancer has been confirmed and my blood test shows AFP levels over 200ng/ml.My disease came back or didn't respond after standard treatment.I am between 1 and 21 years old.I am mostly active and can care for myself.
Research Study Groups:
This trial has the following groups:- Group 1: ET140203 T Cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients able to sign up for this trial at this moment?
"The correct, this trial is open and recruiting patients as the most recent update on clinicaltrials.gov was on October 11th, 2022. This study was originally posted on July 19th, 2020 and is looking for 25 more participants that will be drawn from 2 different locations."
Answered by AI
Does this experiment only include seniors as test subjects?
"According to the age restrictions set out in this study, potential participants must be between 1 and 21 years old."
Answered by AI
How many people are signing up to participate in this research?
"That is correct, the online information hosted on clinicaltrials.gov indicates that this study is still recruiting patients. The posting went up on 7/19/2022 and was updated as recently as 10/11/2022. They are looking for a total of 25 participants who will be seen at 2 different locations."
Answered by AI
To whom does this research project extend an invitation?
"We are looking for 25 participants that have had liver neoplasms and meet the age requirement of being between 1 and 21 years old. Most importantly, patients must also fit the following profile: they must have relapsed or been unresponsive to initial standard-of-care treatment and have a Child-Pugh score of B7 or better. Lastly, per the opinion of the Principal Investigator, participants should have a life expectancy exceeding 4 months."
Answered by AI
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