ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma
NCT ID: NCT03888859
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
12 participants
INTERVENTIONAL
2017-12-06
2020-12-08
Brief Summary
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Detailed Description
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Patients with lesion(s) localized in liver will be enrolled in the intra-hepatic artery (IA) arm or Intratumoral Injections arm, with the ET1402L1-ARTEMIS™2 T-cells administered via intrahepatic artery catheter. Patients with extrahepatic metastasis will be enrolled in the intravenous (IV) arm, with the ET1402L1-ARTEMIS™2 T-cells administered through intravenous infusion.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Intravenous (i.v.) arm
autologous ET1402L1-ARTEMIS™2 T cells administered by intravenous (IV) infusion
ET1402L1-ARTEMIS™ T cells -IV
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct -intravenous (i.v.) arm
Intra-hepatic artery (i.a.) arm
autologous ET1402L1-ARTEMIS™2 T cells administered by intra-hepatic artery (IA) infusion
ET1402L1-ARTEMIS™ T cells -intra-hepatic artery
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: intra-hepatic artery (i.a.) arm
Intratumoral Injections (i.t.) arm
autologous ET1402L1-ARTEMIS™2 T cells administered by intratumoral injections (i.t.) infusion
ET1402L1-ARTEMIS™ T cells -Intratumoral Injections
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: Intratumoral Injections (i.t.) arm
Interventions
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ET1402L1-ARTEMIS™ T cells -IV
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct -intravenous (i.v.) arm
ET1402L1-ARTEMIS™ T cells -intra-hepatic artery
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: intra-hepatic artery (i.a.) arm
ET1402L1-ARTEMIS™ T cells -Intratumoral Injections
Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: Intratumoral Injections (i.t.) arm
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Eureka Therapeutics Inc.
INDUSTRY
Aeon Therapeutics (Shanghai) Co., Ltd.
INDUSTRY
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Chang Liu, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Countries
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Other Identifiers
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XJTU1AF2017LSL-C002
Identifier Type: -
Identifier Source: org_study_id
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