Study on ET140203 T Cells for Children and Young Adults with Liver Cancer

Sponsor: Eureka Therapeutics Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04634357

Provider View

This clinical trial is testing a new treatment using ET140203 T cells for children and young adults with certain types of liver cancer that have returned or not responded to standard treatments. The study aims to find a safe and effective dose for future research.

Patient Parameters

Program Overview

This study is exploring a new treatment using ET140203 T cells for children and young adults with specific liver cancers, such as hepatoblastoma, hepatocellular carcinoma, or HCN-NOS, that have either come back after treatment or have not responded to standard therapies. The trial will determine the safest and most effective dose of the treatment. Participants will be monitored for their response to the treatment over two years, with regular check-ups and imaging tests to see how the cancer is responding. The study will also follow participants for 15 years to ensure the treatment's safety and to track their overall health.

Description

The trial begins with a phase where different doses of the ET140203 T cells are tested to find the safest and most effective dose. This is done using a method where small groups of participants receive increasing doses until the best dose is identified. Once the optimal dose is determined, more participants will receive this dose in the next phase of the trial.

Participants will have their cancer assessed at several points during the study: at 1, 3, 6, 9, 12, 18, and 24 months after starting treatment. These assessments will include imaging tests like CT scans and blood tests to measure AFP levels, a marker associated with liver cancer.

The active part of the study lasts for two years, but participants will be followed for 15 years after treatment to monitor long-term safety and survival.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific liver cancers (hepatoblastoma, HCN-NOS, or hepatocellular carcinoma) with AFP levels over 100 ng/mL.
  • Cancer has returned after initial treatment or has not responded to standard treatment.
  • Aged between 1 and 21 years.
  • Have a specific genetic marker called HLA-A2.
  • Expected to live more than 4 months according to the doctor.
  • Have a performance status score of 70 or higher, indicating they are able to carry out normal activities with some effort.
  • For the initial phase, must have at least one tumor 5 mm or larger, or multiple tumors 3 mm or larger. For the expansion phase, must have measurable disease by specific criteria.
  • Have a Child-Pugh score of A6 or better, indicating good liver function.
  • Have adequate organ function.

Exclusion Criteria

  • Candidates for complete surgical removal of the cancer.
  • Have other serious health conditions that would interfere with the study.
  • Have active, uncontrolled infections. Those with HIV, hepatitis B, or C can participate if their infection is controlled.
  • Have another active cancer besides the ones being studied.
  • Pregnant or breastfeeding women.
  • Have received certain cancer treatments or medications within two weeks before starting the study.
  • Participating in other clinical trials or receiving other investigational treatments.
  • Have conditions that prevent the use of specific chemotherapy drugs.
  • Have active autoimmune diseases requiring treatment.
  • Have blocked blood vessels in the liver that would make participation unsafe.
  • Have had an organ transplant.
  • Have cancer involving more than 50% of the liver.

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