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CAR T-cell Therapy

ECT204 T-Cell Therapy for Liver Cancer (ARYA-3 Trial)

Phase 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

GPC3-positive expression in HCC tumor cells by immunohistochemistry (IHC)

Karnofsky Performance Scale ≥ 70

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

ARYA-3 Trial Summary

This trial will test a new T-cell therapy to treat advanced liver cancer that has failed other treatments. The goal is to find the safe dose and to see if the treatment works.

Who is the study for?

Adults with advanced liver cancer (HCC) who have tried at least two treatments without success can join this trial. They should have a life expectancy of 4+ months, good organ function, and their cancer must show GPC3-positive expression. A score indicating mild liver disease (Child-Pugh A6 or better) and a performance status showing they're mostly independent are also required.Check my eligibility

What is being tested?

The ECT204 T-cell therapy is being tested in adults with HCC that's not removable by surgery or has spread. This Phase I/II trial will determine the safest dose to use while checking how well it works against liver cancer.See study design

What are the potential side effects?

While specific side effects for ECT204 T cells aren't listed here, similar therapies often cause immune reactions, fatigue, fever, and potential harm to healthy tissues due to an overactive immune response.

ARYA-3 Trial Eligibility Criteria

Inclusion Criteria

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

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My liver cancer cells test positive for GPC3.

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I am able to care for myself but may not be able to do active work.

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I have tried at least two treatments for liver cancer that didn't work or caused side effects.

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My liver cancer cannot be removed by surgery and has come back or spread.

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My liver functions well enough for treatment.

ARYA-3 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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the safety and tolerability of ECT204 in adult subjects with advanced HCC

To determine the Recommended Phase II Dose (RP2D) of ECT204 (Concluded During Phase 1 of the study)

Secondary outcome measures

To assess the efficacy of ECT204 in adult subjects with advanced HCC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (RECIST v1.1) as the primary criterion.

To characterize the pharmacokinetic (PK) profile of ECT204, including the expansion and persistence of ECT204, in our study subject population

ARYA-3 Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment2 Interventions

Approximately 10-15 subjects will receive ECT204 at the RP2D by intravenous infusion and preceded by cyclophosphamide and fludarabine chemotherapy for lymphodepletion. Arm B subjects will also receive pre-treatment with regorafenib (STIVARGA®) before ECT204 administration.

Group II: Arm AExperimental Treatment1 Intervention

Approximately 10-15 subjects will receive ECT204 at the RP2D by intravenous infusion and preceded by cyclophosphamide and fludarabine chemotherapy for lymphodepletion.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Eureka Therapeutics Inc.Lead Sponsor

11 Previous Clinical Trials

130 Total Patients Enrolled

6 Trials studying Liver Cancer

65 Patients Enrolled for Liver Cancer

Pei Wang, PhDStudy DirectorEureka Therapeutics Inc.

3 Previous Clinical Trials

42 Total Patients Enrolled

2 Trials studying Liver Cancer

21 Patients Enrolled for Liver Cancer

Media Library

ECT204 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04864054 — Phase 2

Liver Cancer Research Study Groups: Arm A, Arm B

Liver Cancer Clinical Trial 2023: ECT204 T cells Highlights & Side Effects. Trial Name: NCT04864054 — Phase 2

ECT204 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04864054 — Phase 2

Frequently Asked Questions

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

Are there any available slots in this clinical trial for participants?

"According to data hosted on clinicaltrials.gov, this medical research is currently recruiting participants. It was initially released on March 11th 2022 and revised most recently on July 1st 2022."

Answered by AI

What goals are being sought after with this medical experiment?

"The primary aim of the trial, to be carried out over 28 days, is determining the Recommended Phase 2 Dose (RP2D) of ECT204 T cells. Secondary objectives include establishing Time of Maximum Concentration (Tmax), evaluating efficacy according to Radiographic Evaluation Criteria for Solid Tumors (RECIST and iRECIST criteria), and ascertaining Maximum Concentration (Cmax)."

Answered by AI

To what extent has recruitment for this research endeavor been accomplished?

"Affirmative. According to clinicaltrials.gov, this medical study is actively recruiting participants since its initial posting on March 11th 2022 and most recent update on July 1st 2022. The trial seeks 12 individuals from two different locations for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

T-Cell Therapy (ECT204) in Adults With Advanced HCC

2022. "T-Cell Therapy (ECT204) in Adults With Advanced HCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04864054.