NCT02723942

Brief Summary

The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell immunotherapy for GPC3 positive hepatocellular carcinoma.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

March 20, 2016

Last Update Submit

July 14, 2020

Conditions

GPC3 Positive Hepatocellular CarcinomaCAR-T Cell Immunotherapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Radiological assessment

    Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

    3 months

Secondary Outcomes (3)

  • The safety of CAR-T cell immunotherapy (adverse events)

    4 weeks

  • Peripheral blood tumor markers

    3 months

  • CAR-T cell testing

    3 months

Study Arms (2)

CAR-T cell immunotherapy

EXPERIMENTAL

Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen by infusion.

Biological: CAR-T cell immunotherapy

no intervention

NO INTERVENTION

no intervention

Interventions

CAR-T cell immunotherapyBIOLOGICAL

This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.

CAR-T cell immunotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age:18-70 years.
  • Gender:both.
  • GPC3 high expression hepatocellular carcinoma patients.
  • Non diffuse hepatocellular carcinoma，no extrahepatic metastasis or portal vein vascular invasion.
  • Degree of liver cirrhosis：class A or class B 7 according to Child-puge grading standard.
  • Routine blood test：white blood cell count（WBC)\>=3×10\^9/L, Lymphocyte percentage\>=15%, hemoglobinHbo（Hb）\>=90g/L, prothrombin time（PT） prolongation\<=50% normal value, Cluster of differentiation 3(CD3) positive T cell count\>=0.8×10\^9/L.
  • Liver and Pancreatic function：Alanine aminotransferase/Aspartate transaminase(ALT/AST)\<=5 times of the normal value, total bilirubin(TBiL)\<=3.0mg/dL, albumin(ALB)\>=35g/L, prothrombin time(PT):International Normalized Ratio(INR)\<=1.7 or prothrombin time(PT) prolongation\<=4s, Serum lipase\<=1.5 times of the normal value, Serum amylase\<=1.5 times of the normal value.
  • Renal function：Serum creatinine(SCr)\<=221μmol/L(2.5mg/L).
  • Karnofsky Performance Status(KPS)\>=60；Expected survival time\>=12 weeks.
  • Peripheral venous access ；no contraindication of lymphocyte separation.
  • No other serious complications.
  • Voluntarily signed informed consent.

You may not qualify if:

  • Pregnant and lactating women.
  • Lymphocyte separation or peripheral venous access cannot be performed in patients .
  • Patients in the active stage of infection or with coagulation disorders.
  • Patients with a previous history of hepatic coma.
  • Patients with severe gastrointestinal ulcers or gastrointestinal bleeding.
  • Patients with organ transplantation or waiting for organ transplantation.
  • Patients with anticoagulant therapy.
  • Patients with antiplatelet therapy.
  • Serum sodium(Na)\<125 mmol/L.
  • Serum potassium(K)\<3.5 mmol/L(except patients up to the standards after the use of supplements).
  • Patients with organ failure：
  • cardiac function：level three or above according to New York Heart Association (NYHA) criteria.
  • liver function:class C or above according to Child-puge grading standard.
  • renal function:Chronic kidney disease(CKD) phase 4 or more; renal insufficiency phase Ⅲ or more.
  • pulmonary function：severe respiratory failure symptoms, involving other organs.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Simpson-Golabi-Behmel syndromeCarcinoma, Hepatocellular

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Lizhi Niu, PhD

    Fuda Cancer Hospital

    STUDY CHAIR
0

Study Design

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

Study Record Dates

First Submitted

March 20, 2016

First Posted

March 31, 2016

Study Start

June 1, 2015

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

CN(1)