Clinical trial NCT04951141: Clinical Study of Intratumoral Injection of CAR-T Cells in the Treatment of Advanced Liver Tumors
Official title: Beijing Immunochina Medical Science & Technology Co., Ltd.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma , Cholangiocarcinoma
Lead sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* GPC3 expression was positive by histological examination;
* 18-69 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adverse events attributed to the administration of the anti-GPC3 CAR-T cells
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hospital
Study officials:
affiliation: Beijing 302 Hospital
name: Yin ying Lu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: