ET 140202 -T Cell Combined With TAE or Sorafenib in the Treatment of Liver Cancer

NCT03965546 | Unknown Early Phase 1

• 1 other identifier: 2019（ZD13）
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ET 140202 -T cell combined With TAE or Sorafenib in the treatment of liver cancer

Conditions

Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Metastatic Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Frequency of ARTEMIS T cell treatment-related adverse events

  Include but not limited to: Fever, chills, nausea, vomiting, jaundice and other gastrointestinal symptoms; Fatigue, hypotension, respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction. Assessed at all visits.

  28 days up to 2 years

Secondary Outcomes (13)

• Rate of disease response by RECIST in the liver

  2 years

• Rate of disease response by RECIST at non-liver sites

  2 years

• Progression free survival (PFS)

  at 4 months, 1 year, 2 years

• Median Survival（MS）

  at 4 months, 1 year, 2 years

• Overall survival（OS）

  at 2 years

Study Arms (3)

ET140202-T cell combine with Sorafenib

EXPERIMENTAL

Sorafenib treatment everyday and autologous ET140202-T cell administered by intravenous (IV) infusion

Combination Product: Sorafenib combined with ET140202-T cell

ET140202-T cell combine with TAE

EXPERIMENTAL

TAE treatment ahead every two times of autologous ET140202-T cell administered by intravenous (IV) infusion

Combination Product: TAE combined with ET140202-T cell

solo ET140202-T cell

EXPERIMENTAL

autologous ET140202-T cell administered by intravenous (IV) infusion

Biological: ET140202-T cell

Interventions

Sorafenib combined with ET140202-T cell COMBINATION_PRODUCT

1. Sorafenib starting dose of 400mg b.i.d. a.c. 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion

ET140202-T cell combine with Sorafenib

TAE combined with ET140202-T cell COMBINATION_PRODUCT

1. Transarterial embolization(TAE) treatment 2. Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)

ET140202-T cell combine with TAE

ET140202-T cell BIOLOGICAL

Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)

solo ET140202-T cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AFP-expressing HCC and serum AFP \>10 x ULN
• 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, ECOG 0-2, Life expectancy \> 6 months
• Measurable disease as defined by: at least 1 liver lesion that can be accurately and serially measured.
• Negative serum pregnancy test for women with childbearing potential
• Adequate organ function as defined below:
• A pretreatment measured creatinine clearance (absolute value) of ≥50 ml/minute.
• Patients must have a serum direct bilirubin ≤3 x ULN, ALT and AST ≤5 x ULN.
• Ejection Fraction measured by echocardiogram or MUGA \>50% (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)
• INR ≤1.5 x ULN
• Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Eureka Therapeutics Inc.: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xue Hui, PHD

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

Yun Wang, PHD

CONTACT

86-18681869114; foolishyun@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: May 30, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: August 8, 2019

Record last verified: 2019-05

Locations

CN (1)