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ET1402L1-ARTEMIS™2 T Cells in Alpha Fetoprotein (AFP) Expressing Hepatocellular Carcinoma

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Xi'an Jiaotong University

Status and phase

Completed
Early Phase 1

Conditions

Liver Neoplasms
Metastatic Liver Cancer
Hepatocellular Carcinoma
Liver Cancer

Treatments

Biological: ET1402L1-ARTEMIS™ T cells -Intratumoral Injections
Biological: ET1402L1-ARTEMIS™ T cells -intra-hepatic artery
Biological: ET1402L1-ARTEMIS™ T cells -IV

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03888859
XJTU1AF2017LSL-C002

Details and patient eligibility

About

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).

Full description

The molecular target for ET1402L1-ARTEMIS™2 is human leukocyte antigen (HLA) -A02 complexed with a HLA-A02-restricted peptide of alpha fetoprotein (AFP), which is expressed on 60-80 percent of hepatocellular carcinoma (HCC). ARTEMIS™2 is a second generation ARTEMIS™ receptor engineered with a human antibody domain against the anti-HLA-A02/AFP complex. This clinical study evaluates the safety and pharmacokinetics of ET1402L1-ARTEMIS™2 T-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 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.

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Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

12 participants in 3 patient groups

Intravenous (i.v.) arm
Experimental group
Description:
autologous ET1402L1-ARTEMIS™2 T cells administered by intravenous (IV) infusion
Treatment:
Biological: ET1402L1-ARTEMIS™ T cells -IV
Intra-hepatic artery (i.a.) arm
Experimental group
Description:
autologous ET1402L1-ARTEMIS™2 T cells administered by intra-hepatic artery (IA) infusion
Treatment:
Biological: ET1402L1-ARTEMIS™ T cells -intra-hepatic artery
Intratumoral Injections (i.t.) arm
Experimental group
Description:
autologous ET1402L1-ARTEMIS™2 T cells administered by intratumoral injections (i.t.) infusion
Treatment:
Biological: ET1402L1-ARTEMIS™ T cells -Intratumoral Injections

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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