NCT03084380

Brief Summary

The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 5, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

March 5, 2017

Last Update Submit

March 17, 2017

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

    Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

    4 weeks

Secondary Outcomes (2)

  • Efficacy: Overall complete remission rate defined by the standard response criteria

    8 weeks

  • Persistence: Duration of CAR-positive T cells in circulation

    6 months

Study Arms (1)

anti-GPC3 CAR-T

EXPERIMENTAL

Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion

Biological: Retroviral vector-transduced autologous T cells to express anti-GPC3 CARsDrug: FludarabineDrug: Cyclophosphamide

Interventions

Retroviral vector-transduced autologous T cells to express anti-GPC3 CARsBIOLOGICAL

transcatheter arterial chemoembolization + CAR-T infusion

anti-GPC3 CAR-T
FludarabineDRUG

Fludarabine will be administered at dose of 25mg/m2/d

anti-GPC3 CAR-T
CyclophosphamideDRUG

Cyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered

anti-GPC3 CAR-T

Eligibility Criteria

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

You may qualify if:

  • Expected to survive more than 3 months
  • PS 0-2
  • Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma
  • Patients with no ability to receive TACE combined with sorafenib
  • WBC\>3.5×1e+9/L,Hb\>90g/L,PLT\>75×1e+9/L
  • HBV DNA copy number less than 100/ml
  • ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
  • Understand this test and have signed informed consent

You may not qualify if:

  • Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
  • Decompensated liver cirrhosis, liver function Child-pugh C grade
  • Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
  • Long-term use of immunosuppressive agents after organ transplantation
  • Screening indicated that the target cell transfection rate was less than 30%
  • Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
  • Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
  • Pregnant or lactating subjects
  • In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
  • Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Xinqiao Hospital

Chongqing, Chongqing Municipality, 400037, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

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
Secretary of research

Study Record Dates

First Submitted

March 5, 2017

First Posted

March 20, 2017

Study Start

June 1, 2017

Primary Completion

May 31, 2019

Study Completion

May 31, 2020

Last Updated

March 20, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)