Clinical trial · Interventional
ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma
Phase 1, Open-label, Three Routes IV, Intratumoral Injections and Intra-hepatic Artery Dose-escalation Clinical Study to Evaluate the Safety and Efficacy of ET1402L1-ARTEMIS™2™ T- Cells in AFP Expressing Hepatocellular Carcinoma (HCC)
NCT03888859CI-TRIAL-00050918completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical study to evaluate safety (primary objectives) and efficacy (secondary objective) of ET1402L1-ARTEMIS™2 T cells in patients with alpha fetoprotein positive (AFP+ ) 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 Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ET1402L1-ARTEMIS™ T cells -intra-hepatic artery | Biological | — | UNRESOLVED |
| ET1402L1-ARTEMIS™ T cells -Intratumoral Injections | Biological | — | UNRESOLVED |
| ET1402L1-ARTEMIS™ T cells -IV | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intravenous (i.v.) arm
- description
- autologous ET1402L1-ARTEMIS™2 T cells administered by intravenous (IV) infusion
- interventionNames
- Biological: ET1402L1-ARTEMIS™ T cells -IV
- type
- EXPERIMENTAL
- label
- Intra-hepatic artery (i.a.) arm
- description
- autologous ET1402L1-ARTEMIS™2 T cells administered by intra-hepatic artery (IA) infusion
- interventionNames
- Biological: ET1402L1-ARTEMIS™ T cells -intra-hepatic artery
- type
- EXPERIMENTAL
- label
- Intratumoral Injections (i.t.) arm
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * AFP-expressing HCC and serum AFP \>100 ng/mL. * Abandon or failure in first or second line treatment * Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele * Child-Pugh score of A or B, Barcelona Clinic Liver Cancer stage of C or D * Life expectancy \> 4 months * Karnofsky score ≥70% * Adequate organ function as defined below: 1. Patients must have a serum Total bilirubin ≤2 x Upper Limit of Normal (ULN), Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤5 times the institutional ULN. 2. A pretreatment measured creatinine clearance (absolute value) of ≥ 50 ml/minute 3. Ejection fraction measured by echocardiogram or Multiple gated acquisition scanning (MUGA) \>45% (evaluation done with 6 weeks of screening does not need to be repeated) 4. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) or Forced Expiratory Volume in the first second (FEV1)\>45% predicted 5. Absolute neutrophil count (ANC) ≥ 1500/mm3 (10\^9/L) 6. Platelet count ≥ 50,000/mm3 (10\^9/L) * Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Patients with decompensated cirrhosis: Child-Pugh Score C * Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver. * Patients with an organ transplantation history * Patients with dependence on corticosteroids * Patients with active autoimmune diseases requiring systemic immunosuppressive therapy * Patients who are currently receiving or received within past 30 days anti-cancer therapy, local treatments for liver tumors (radiotherapy, embolism, ablation) or liver surgery * Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy) * Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within two years. Patients with a history of successfully-treated tumors with no sign of recurrence in the last two years may be enrolled. * Patients with other uncontrolled diseases, such as active infections * Acute or chronic active hepatitis B or hepatitis C. * Women who are pregnant or breast-feed * HIV-infection
References
Publications (0)
Data not yet available
No reference posted for this study.