Clinical trial · Interventional
Clinical Study of ET1402L1-CAR T Cells in AFP Expressing Hepatocellular Carcinoma
Phase 1, Open-label, Two Routes IV and Intra-hepatic Artery Dose-escalation Clinical Study to Evaluate the Safety and Efficacy of ET1402L1-CAR T- Cells in AFP Expressing Hepatocellular Carcinoma (HCC)
NCT03349255CI-TRIAL-00039269terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Will study new T-cell construct for the same indication
Summary
Brief summary (as posted)
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous ET1402L1-CART cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- intravenous (i.v.) arm
- description
- autologous ET1402L1-CART cells administered by intravenous (IV) infusion
- interventionNames
- Biological: autologous ET1402L1-CART cells
- type
- EXPERIMENTAL
- label
- intra-hepatic artery (i.a.) arm
- description
- autologous ET1402L1-CART cells administered by intra-hepatic artery (IA) infusion
- interventionNames
- Biological: autologous ET1402L1-CART cells
Primary outcomes (2)
- measure
- Number of patients with dose-limiting toxicity
- timeFrame
- 28 days up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AFP-expressing HCC and serum AFP \>100 ng/mL. * Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 20 mm. * Molecular HLA class I typing confirms participant carries at least one HLA-A02 allele * Child-Pugh score of A or B * Life expectancy \> 4 months * Age at time of enrollment is ≥18 years of age. * KPS ≥70% * Adequate organ function as defined below: * A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute. * Patients must have a serum direct bilirubin ≤2 x ULN, ALT and AST ≤5 times the institutional upper limits of normal. * Ejection Fraction measured by echocardiogram or MUGA \>45% (evaluation done within 6 weeks of screening does not need to be repeated) * DLCO or FEV1 \>45% predicted * Absolute neutrophil count (ANC) ≥ 1500/mm3 (10\^9/L) * Platelet count ≥ 50,000/mm3 (10\^9/L) * Negative serum pregnancy test for women with childbearing potential * 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 an organ transplantation history * Patients with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver. * 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) * Patients undergoing current treatment known to interfere with lymphodepleting chemotherapy (cyclophosphamide, etc.). * 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. * HIV-infection * Women who are pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.