Clinical Study on the Efficacy and Safety of c-Met/PD-L1 CAR-T Cell Injection in the Treatment of HCC
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|ClinicalTrials.gov Identifier: NCT03672305|
Recruitment Status : Unknown
Verified September 2018 by LiTao, The Second Hospital of Nanjing Medical University.
Recruitment status was: Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 18, 2018
Title: Single-center, open clinical study on the efficacy and safety of c-Met/PD-L1 T cell injection in the treatment of primary hepatocellular carcinoma
Stage: Phase I clinical trial
Purpose: To evaluate the efficacy and safety of c-Met/PD-L1 CAR-T cells in patients with primary hepatocellular carcinoma
Object: patients with primary hepatocellular carcinoma
Sample size: 50 cases
Number of centres：1
Study design: CT, MRI, PET and blood biochemical tests were performed before treatment to evaluate the state of HCC. Peripheral blood of the patient was extracted and PBMC was isolated. CAR-T cells were obtained by tranducing PBMC with c-Met/PD-L1 CAR lentivirus, and the proliferation capacity and immune phenotype of the cells were tested. After passing the inspection, the cells were re-injected into the patient three times. The efficacy and safety of c-Met/PD-L1 CAR-T cells was assessed respectively at 4 week, 12 week, 24 week and 48 week after treatment.
Trial product: c-Met/PD-L1 CAR-T cells
Course of treatment: 3 days for a course of treatment, only one course of treatment. A second course is given as appropriate if the treatment is beneficial to the patient.
|Condition or disease||Intervention/treatment||Phase|
|Primary Hepatocellular Carcinoma||Biological: c-Met/PD-L1 CAR-T cell injection||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-center, Open Clinical Study on the Efficacy and Safety of c-Met/PD-L1 Chimeric Antigen Receptor T Cell Injection in the Treatment of Primary Hepatocellular Carcinoma|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||October 30, 2019|
c-Met/PD-L1 CAR-T cells treating group
Intervention Name:c-Met/PD-L1 CAR-T cell injection dosage form: injection dosage:The backtransfusion dose (recommended dose: 2 * 10^6/kg) was determined by the investigator based on the subject's own/disease condition and in vitro preparation.
Biological: c-Met/PD-L1 CAR-T cell injection
injection content:c-Met/PD-L1 CAR-T cell Infusion way:Steady intravenous drip in 15 to 30 minutes
- The efficacy of c-Met/PD-L1 CAR-T cells in the treatment of HCC [ Time Frame: 6 months after treatment ]assessing the efficacy of c-Met/PD-L1 CAR-T cells through overall survival
- the incidence of treatment-emergent adverse events of c-Met/PD-L1 T cell injection in the treatment of HCC [ Time Frame: 6 months after treatment ]the level 3 or level 4 adverse reactions according to CTCAE V4.03 standard
- The amplification and persistence of c-Met/PD-L1 CAR-T cell in the subjects varied with time [ Time Frame: 6 months after treatment ]The amplification level of c-Met/PD-L1 CAR-T cells varied with time and the duration of anti-c-met/pd-l1 CAR-T cells in the subjects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672305
|Contact: Guozhong Ji, archiater||+86-13951031818||J58430@njmu.edu.cn|
|Study Chair:||Guozhong Ji, archiater||Second affiliated hospital of nanjing medical university|