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) (ARYA-2)

  • End date
    Feb 28, 2025
  • participants needed
  • sponsor
    Eureka Therapeutics Inc.
Updated on 27 October 2022
measurable disease


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.


The trial starts with a dose escalation phase. A traditional dose escalation model (3+3) design will be used to determine the recommended phase II dose (RP2D). Subjects will then be treated at the RP2D in the expansion phase of the trial.

Following treatment, tumor response assessments will be performed at Months 1, 3, 6, 9, 12, 18, and 24. At each tumor response assessment visit, imaging will be performed (triphasic CT Scan) and used for response evaluation. Serum AFP levels will also be measured at each tumor response assessment visit.

The active assessment phase of the study will continue for 2 years. Subjects will be followed for 15 years post-treatment for assessment of treatment safety and overall survival.

Condition Hepatoblastoma, Hepatocellular Carcinoma (HCC), Liver Neoplasms, Metastatic Liver Cancer, Liver Cancer, HEMNOS
Treatment ET140203 T Cells
Clinical Study IdentifierNCT04634357
SponsorEureka Therapeutics Inc.
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed HB, HCN-NOS, or HCC with serum AFP >200ng/ml at the time of screening and following the most recent line of therapy
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
Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele
Life expectancy of > 4 months per Principal Investigator's opinion
Lansky or Karnofsky Performance Scale ≥ 70
For enrollment to the dose-finding cohort, subjects must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, subjects must have measurable disease by RECIST v1.1
Child-Pugh score of B7 or better
Adequate organ function

Exclusion Criteria

Received the following within two (2) weeks of leukapheresis and within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, systemic corticosteroids, other anti-cancer therapies (including immunotherapeutic agents), or any other immunosuppressive agents (Note: use of inhaled or topical steroids is not exclusionary)
Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study
Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide
Active autoimmune disease requiring systemic immunosuppressive therapy
Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Principal Investigator, would make the subject unsuitable for the study
History of organ transplant
HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric)
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