GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC

NCT04121273 | Unknown Phase 1

• 1 other identifier: v1.0 20180620
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment. Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells. The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

chimeric antigen receptor T cell (CAR- T); glypican-3 (GPC3); hepatocellular carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Number of patient with dose limiting toxicity

  After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed.

  2 months

Secondary Outcomes (3)

• Radiological evaluation of tumor size after CAR- T immunotherapy

  3 months

• Peripheral tumor marker

  3 months

• Number of Peripheral CAR-T cell

  3 months

Study Arms (1)

CAR-T cells

EXPERIMENTAL

CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma.

Biological: CAR-T cell immunotherapy

Interventions

CAR-T cell immunotherapy BIOLOGICAL

Patients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows: Dose 1: 1x10\^7/m2 Dose 2: 3x10\^7/m2 Dose 3: 1x10\^8/m2 The cell numbers are calculated according to CAR-positive T cells.

CAR-T cells

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• GPC3 positive HCC, tumor size \>= 5 cm, cannot receive standard treatment, Expected survival time\>=3 months.
• Routine blood test: white blood cell count（WBC)\>= 2.5×10\^9/L, hemoglobin (Hb)\>= 9.0 g/dL, blood platelet \>= 60×10\^9/L, Lymphocyte percentage\>=15%.
• Blood biochemical parameters: ALB \>= 30 g/L, ALT \<= 5 times of the normal value, AST \<= 5 times of the normal value, serum lipase\<=1.5 times of the normal value, serum amylase\<=1.5 times of the normal value， total bilirubin \<= 2.5 times of the normal value.
• Prothrombin time INR \< 1.7.
• Ejection fraction (EF) \>= 55%, oxygen saturation (SO2) \> 90%.
• No allergic reaction to contrast material.
• Karnofsky score \>= 60%.
• Child-puge score \<7.
• Peripheral venous access.
• Voluntarily signed informed consent.

You may not qualify if:

• Pregnancy or lactation.
• Systemic steroid treatment ( \>prednisone equivalent/kg/day).
• Patients with previous history of cell immunotherapy or antibody therapy.
• Patients received radiotherapy/chemotherapy in the past 4 weeks.
• Patients are participating in other clinical trials.
• Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
• Patients with acute allergic reaction.
• History of liver transplantation.
• Patients with anticoagulant treatment.
• Patients with hepatic encephalopathy.
• Eligible for hepatectomy, liver transplantation or other standard treatment.
• Unstable gastrointestinal and respiratory bleeding.
• Active viral, fungal or bacterial infections.
• Heart failure classification (NYHA): II-IV.
• Patients are unable or unwilling to comply with the requirements of the study protocol.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Simpson-Golabi-Behmel syndrome

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Decai Yu, MD

CONTACT

8613701585023; yudecai@nju.edu.cn

Wenfang Tian, PhD

CONTACT

8613675104348; tiancpu@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hepatobiliary Surgery

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: October 5, 2019
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)