Clinical Study of Intratumoral Injection of CAR-T Cells in the Treatment of Advanced Liver Tumors

NCT04951141 | Unknown Early Phase 1

• 1 other identifier: 2017-003-D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.

Conditions

Hepatocellular Carcinoma , Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Adverse events attributed to the administration of the anti-GPC3 CAR-T cells

  2 years

Secondary Outcomes (2)

• Objective response rate (ORR)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

anti-GPC3 CAR-T

EXPERIMENTAL

Biological: anti-GPC3 CAR-T cells

Interventions

anti-GPC3 CAR-T cells BIOLOGICAL

A single arm, open-label pilot study is designed to determine the safety and efficacy of anti-GPC3 CAR-T cells in patients with GPC3-positive advanced liver cancer.

anti-GPC3 CAR-T

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 expression was positive by histological examination;
• years old;
• The patients with advanced liver tumor who can not be operated and the effect of chemotherapy is poor;
• The patients who received traditional palliative therapy had an expected survival period of more than 4 months;
• Organ status allows clinical application.a. Creatinine \< 1.5mg/dl; b. Cardiac ejection index \> 55%; c. Heme \> 9g / dl, bilirubin \< 2.0mg/dl;
• No bleeding and coagulation disorders were found;
• There was no allergy to contrast medium;
• Contraception: contraceptive measures were taken during clinical application and within 3 months after the last cells transfusion;
• There is no other contraindication for lymphocyte collection;
• Sign informed consent.

You may not qualify if:

• Pregnant or lactating women;
• Patients need systemic steroids therapy;
• At present, the treatment conditions are as follows : a. Within 30 days before the collection of peripheral blood mononuclear cells,patiens were in other anti-tumor clinical observation period; b. Patients have not recovered from the acute side effects of previous treatment;
• Patients received radiotherapy within 4 weeks after enrollment;
• Patients received other cell modification therapy in the early stage;
• In the screening stage, patients with lymphocyte transfection rate less than 5%, or T cell culture can not expand (\< 5 times) patients;
• Uncontrolled symptoms or other diseases include, but are not limited to, infection, congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or limiting the social environment that meets the requirements, or the researchers believe that they may bring unpredictable risks;
• Patients with severe acute allergic reactions;
• Patients who participated in other clinical trials;
• Researchers believe that patients are not suitable to participate.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

The Fifth Medical Center of Chinese PLA General Hospital

Beijing, 100039, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Yin ying Lu, M.D.

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Wu

CONTACT

+8615801390058; wufei@immunochina.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: July 6, 2021
• Study Start: January 1, 2019
• Primary Completion: September 30, 2023
• Study Completion: December 21, 2023
• Last Updated: July 6, 2021

Record last verified: 2021-06

Locations

CN (1)