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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 : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
LiTao, The Second Hospital of Nanjing Medical University

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 18 to 70 years (including 18 and 70 years);
  2. Immune histochemistry detection was confirmed as c-met positive ; hepatocellular carcinoma, and the patient has no effective treatment at present
  3. Liver tissue type: non-diffuse hepatocellular carcinoma, no extra hepatic metastasis or portal vein infiltration;
  4. Cirrhosis of the liver: child-pugh A grade or child-pugh B grade, child-pugh-turcotte score <7;
  5. Routine blood test: white blood cell count (WBC) or 3 * 10^9/L, lymphocyte percentage (LY) 15% or higher, hemoglobin (Hb), 90g/L or higher, prothrombin time (PT), international standardization ratio (INR) 1.7 or less, or prothrombin time (PT) extend the 4 s or less, lymphocyte acuity 0.8 * 10^9/L;
  6. The main tissues and organs of the patients are functioning well (if the organs do not meet the following standards, but the researchers believe that the diseases themselves can be included):

    1. Hepatic and pancreatic functions: alanine aminotransferase/aspartate aminotransferase (ALT/AST) is 5 times of normal value, total bilirubin (TBiL) is 3.0mg/dL, albumin (ALB) is 35g/L, serum lipase is 1.5 times of normal value, and serum amylase is 1.5 times of normal value. Renal function: creatinine <2 ULN
    2. Lung function: indoor oxygen saturation greater than or equal to 95% (without oxygen inhalation)
    3. Cardiac function: LVEF is greater than or equal to 40%
    4. The absolute number of neutrophils is greater than or equal to 0.75 * 10^9/L, and platelets are greater than or equal to 50 * 10^9/L
  7. ECOG score 0-1 or Karnofsky performance status (card score) (KPS) is greater than 60, and the expected survival time is greater than or equal to 12 weeks;
  8. There are adequate venipuncture or venous sampling channels and no contraindications for lymphocyte separation;
  9. No anti-tumor therapy, including chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs), was received within 4 weeks before enrollment, and the toxicity response of previous treatment was restored to level 1 or less (except for low-level toxicity such as hair loss);
  10. Female subjects of reproductive age must have negative serum or urine pregnancy test during screening, and male and female patients agree to take effective contraceptive measures during the trial;
  11. There were no other serious complications;
  12. Voluntarily sign informed consent.

Exclusion Criteria:

  1. Women during pregnancy (positive urine/blood pregnancy test) or lactation; A male or female who has a plan to conceive within the last 1 year; Effective contraceptive (condom or birth control pill, etc.) cannot be guaranteed for 1 year after enrollment;
  2. The patients had uncontrollable infection within 4 weeks before enrollment. However, prophylactic antibiotics, antiviral and antifungal infection treatment are allowed; Active hepatitis b hepatitis c; People infected with human immunodeficiency virus (HIV);
  3. Suffering from severe autoimmune disease or immunodeficiency disease;
  4. The patient is allergic to large molecular biological drugs such as antibodies or cytokines;
  5. The patient who has mentally ill;
  6. The patient has substance abuse/addiction;
  7. The patient who has a history of hepatocellular carcinoma;
  8. Having severe peptic ulcer or bleeding;
  9. A patient who receives an organ transplant or waits for one;
  10. Patients requiring anticoagulation (e.g., warfarin or heparin);
  11. Patients requiring long-term antiplatelet therapy (aspirin > 300 mg/d; Clopidogrel dose > 75 mg/d);
  12. Organ failure patient:

    1. Cardiac function: grade 3 or above according to the New York heart association (NYHA) standard
    2. Liver function: C level above, according to child-pugh standard
    3. Chronic kidney disease (CKD) stage 4 or above; Renal insufficiency or above
    4. Lung function: severe respiratory failure, involving other organs
    5. Brain function: abnormal central nervous system or disturbance of consciousness;
  13. Systemic use of hormones within 4 weeks before enrollment (use of prednisone 20mg/ d or less is allowed, except for inhaled hormones);
  14. The patient participated in other clinical trials within 4 weeks before enrollment;
  15. The patient has been treated with radiation for the past four weeks;
  16. Investigators determined that the patient was unable or unwilling to comply with protocol requirements.

Information from the National Library of Medicine

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


Contacts
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Contact: Guozhong Ji, archiater +86-13951031818 J58430@njmu.edu.cn

Sponsors and Collaborators
The Second Hospital of Nanjing Medical University
Investigators
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Study Chair: Guozhong Ji, archiater Second affiliated hospital of nanjing medical university

Publications:

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Responsible Party: LiTao, Principal Investigator, The Second Hospital of Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03672305     History of Changes
Other Study ID Numbers: JGZNO1
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases