Clinical trial · Interventional
Study of ET140203 T Cells in Adults With Advanced Hepatocellular Carcinoma (ARYA-1)
An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140203 T Cells and Determine the Recommended Phase II Dose (RP2D) in Adults With Advanced Hepatocellular Carcinoma (HCC) (ARYA-1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was intended to be a Phase 1/2 trial, but the sponsor terminated the trial prior to moving to Phase 2 to direct efforts to the pediatric study (ARYA-2) for this product.
Summary
Brief summary (as posted)
Open-label, dose escalation, multi-center, Phase I / II study to assess the safety of an autologous T-cell product (ET140203) in adult subjects with Alpha-fetoprotein (AFP)-positive/Human Leukocyte Antigen (HLA) A-2-positive advanced hepatocellular carcinoma (HCC).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Neoplasm | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ET140203 autologous T cell product | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ET140203 TCells
- description
- ET140203 T Cells
- interventionNames
- Biological: ET140203 autologous T cell product
Primary outcomes (4)
- measure
- Incidence rates of adverse events (AEs) after infusion of ET140203 T cells
- timeFrame
- 28 days
- description
- Safety of ET140203T cells as assessed by the number of adverse events (AEs) after infusion
- measure
- Severity rates of adverse events (AEs) after infusion of ET140203 T cells
- timeFrame
- 28 days
- description
- Safety of ET140203T cells as assessed by the severity of adverse events (AEs) after infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed HCC with serum AFP \>100ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP \>400ng/ml at time of screening and following most current line of therapy.
* Metastatic or locally advanced, unresectable HCC
* Must have failed or not tolerated at least two (2) different anti-HCC systemic agents
* Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele
* Life expectancy of at least 4 months
* Karnofsky Performance Scale greater than or equal to 70
* At least 1 measurable lesion on imaging by RECIST
* Child-Pugh A6 or better
* Absolute neutrophil count greater than or equal to 1,500/mm\^3
* Platelet count greater than or equal to 75,000/mm\^3
Exclusion Criteria:
* Clinically significant cardiac disease
* Clinically significant pre-existing illness or active infection
* Clinically significant Central Nervous System (CNS) or neural dysfunction
* Active autoimmune disease requiring therapy
* Active malignancy other than HCC with the exception of cholangiocarcinoma (CCA) or any malignancy with an expected survival ≥ 3 years without any treatment (exception: hormone/androgen-deprivation therapy) and without any organ involvement
* History of organ transplant
* Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction
* Advanced HCC involving greater than 50% of the liverReferences
Publications (0)
Data not yet available