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Clinical Study of ET1402L1-CAR T Cells in AFP Expressing Hepatocellular Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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)

NCT03349255•Aeon Therapeutics (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC

Detailed Description

The molecular target for ET1402L1-CART is alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). ET1402L1-CART is a second generation (CD28/CD3ζ) chimeric antigen receptor (CAR) engineered with a human single-chain variable antibody fragments (scFv) against the anti-HLA-A02/AFP complex. This clinical study evaluates the safety and pharmacokinetics of ET1402L1-CART-cells in patients with HCC who have no available curative therapeutic options and a poor overall prognosis. Patients with lesion(s) localized in liver will be enrolled in the IA arm, with the ET1402L1-CART-cells administered via intrahepatic artery catheter. Patients with extrahepatic metastasis will be enrolled in the IV arm, with the ET1402L1-CART-cells administered through intravenous infusion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

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:
+3 more criteria

Locations (1)

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Key Dates

Start Date

October 6, 2017

Primary Completion Date

January 10, 2019

Completion Date

January 10, 2019

Last Updated

July 1, 2019

Enrollment

ACTUAL participants

Conditions

Hepatocellular CarcinomaLiver CancerLiver NeoplasmsMetastatic Liver Cancer

Interventions

autologous ET1402L1-CART cells

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of ET1402L1-CAR T Cells in AFP Expressing Hepatocellular Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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