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

15 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGET140203 T Cells

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


Locations(2)

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

For the most up-to-date information, visit the official listing.

Visit

NCT04634357


Related Trials