RecruitingPhase 1Phase 2NCT04634357

ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma

An Open-Label, Dose Escalation, Phase I/II Clinical Trial of ET140203 T Cells in Pediatric Subjects With Relapsed/Refractory Hepatoblastoma (HB), Hepatocellular Neoplasm-Not Otherwise Specified (HCN-NOS), or Hepatocellular Carcinoma (HCC)


Sponsor

Eureka Therapeutics Inc.

Enrollment

12 participants

Start Date

Jul 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety/tolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive/HLA-A2-positive and have relapsed/refractory HB, HCN-NOS, or HCC.


Eligibility

Min Age: 1 YearMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of cell therapy — specially engineered immune cells (T cells) called ET140203 — to treat children and young adults with liver cancers (hepatoblastoma or hepatocellular carcinoma) that have come back or stopped responding to standard treatment. These modified T cells are designed to recognize and attack liver cancer cells. **You may be eligible if...** - You are between 1 and 21 years old - You have been diagnosed with hepatoblastoma (HB), hepatocellular carcinoma (HCC), or a related liver cancer - Your cancer has relapsed or did not respond to standard treatment - Your blood AFP level (a liver cancer marker) is above 100 ng/mL - You carry a specific genetic marker (HLA-A2) that allows the therapy to work - Your liver function and overall health meet minimum requirements **You may NOT be eligible if...** - Your cancer can be completely removed by surgery - You have a serious uncontrolled infection or heart/lung condition - You have very poor liver function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGET140203 T Cells

Biological/Vaccine: ET140203 autologous T-cell product Autologous T cells transduced with lentivirus encoding an ET140203 expression construct


Locations(4)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Orange County

Orange, California, United States

UCSF Benioff Children's Hospitals

San Francisco, California, United States

Dana-Farber/Boston Children's Cancer and Blood Disorders Center

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04634357


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