NCT03993743

Brief Summary

This is a single-center, single-arm, open label and dose escalation clinical study of anti-CD147 CART cells by hepatic artery infusions in patients with advanced hepatocellular carcinoma.

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
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2019

Typical duration for phase_1

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

Study Start

First participant enrolled

May 27, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

June 19, 2019

Last Update Submit

August 24, 2019

Conditions

Advanced Hepatocellular Carcinoma

Keywords

liver cancerCD147CAR-T

Outcome Measures

Primary Outcomes (1)

  • Incidence and type of adverse events induced by CD147-CART hepatic artery infusions

    To assess the safety of CD147-CART (anti-CD147 CAR-T cell) hepatic artery infusions (HAI) for very advanced hepatocellular carcinoma which measured by number and type of adverse events.

    12 weeks

Secondary Outcomes (3)

  • DLT and MTD of CD147-CART cell hepatic artery infusions

    12 weeks

  • Activity of CD147-CART cell hepatic artery infusions

    2 years

  • CD147-CART detection in extrahepatic sites

    2 years

Study Arms (1)

CD147-CART

EXPERIMENTAL

Infusions of CD147-CART cells over the course of each week for 3 times into the hepatic artery

Biological: CD147-CART

Interventions

CD147-CARTBIOLOGICAL

Three infusions of CD147-CART cells over the course of three weeks into the hepatic artery.

Also known as: anti-CD147 chimeric antigen receptor T cell
CD147-CART

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 year and ≤ 65 years, both male and female.
  • Advanced hepatocellular carcinoma(HCC) patient, which is untreatable by surgery or local therapy, or has postoperative progressions, failed at least one and two line of standard systemic chemotherapy, and unwilling or intolerance to targeting therapy or immune-therapy of cancer.
  • The portal vein is not total occlusion, or collateral circulation has formed between hepatic artery and blocked portal vein.
  • Patient with measurable HCC focus defined by mRECIST.
  • Patient with histologically confirmed diagnosis of CD147+ hepatocellular carcinoma.
  • Adequate venous access for apheresis, and no other contraindications for apheresis.
  • Child-Pugh score ≤7.
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0-2.
  • Patient with a life expectancy of greater than three months.
  • Patients must able to understand and be willing to sign an informed consent.

You may not qualify if:

  • Patients with fibrolamellar carcinoma of liver，mixed hepatocellular carcinoma or cholangiocarcinoma.
  • Patients with severe hypohepatia including jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome.
  • Patients with severe comorbidity, including any of the following.
  • Unstable angina pectoris and/or congestive heart failure need hospitalization;
  • Myocardial infarction or cerebrovascular accident (CVA) in the last 6 months;
  • chronic obstructive pulmonary disease progressions or need hospitalization;
  • severe cardiovascular, nervous system, hematological, gastrointestinal, endocrine diseases or metabolic disorders;
  • autoimmune disease or immunodeficiency disease;
  • acute bacterial infections or fungal infections needs intravenous injection of antibiotics during CAR-T cell therapy;
  • tuberculosis not cured;
  • other malignancies;
  • Patients who have received gene therapy, cell therapy or immune therapy.
  • Patients who have received organ transplantation.
  • Patients who have received treatment of targeted drugs, glucocorticoid or immunosuppressive drugs within 2 weeks before enrolling in clinical trial.
  • Patients who have received chemotherapy except for lymphocyte clearance within 2 weeks before enrolling in clinical trial.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of hepato-biliary & Pancreato Splenic Surgery Organ Transplant Center, Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Central Study Contacts

Zhi-Nan Chen, PhD

CONTACT

86-029-84774547znchen@fmmu.edu.cn

Kaishan Tao, Dr

CONTACT

86-029-84775259taokaishan0686@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 National Translational Science Center for Molecular Medicine

Study Record Dates

First Submitted

June 19, 2019

First Posted

June 21, 2019

Study Start

May 27, 2019

Primary Completion

October 27, 2020

Study Completion

May 27, 2022

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

CN(1)