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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.
Must not have
Active autoimmune disease requiring systemic immunosuppressive therapy
Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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My disease came back or didn't respond after standard treatment.
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I am between 1 and 21 years old.
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I am mostly active and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on medication to suppress my immune system due to an autoimmune disease.
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I cannot take certain chemotherapy drugs like Fludarabine and Cyclophosphamide.
Select...
I have had an organ transplant.
Select...
More than half of my liver is affected by cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 more
Secondary study objectives
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.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ET140203 T CellsExperimental Treatment1 Intervention
ET140203 Autologous T Cells

Find a Location

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

ET140203 T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04634357 — Phase 1 & 2
Liver Cancer Research Study Groups: ET140203 T Cells
Liver Cancer Clinical Trial 2023: ET140203 T Cells Highlights & Side Effects. Trial Name: NCT04634357 — Phase 1 & 2
ET140203 T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634357 — Phase 1 & 2
~5 spots leftby Jan 2026
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