Clinical Trials /

A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

NCT03013712

Description:

The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
  • Official Title: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

Clinical Trial IDs

  • ORG STUDY ID: CARTEPC-001
  • NCT ID: NCT03013712

Conditions

  • Colon Cancer
  • Esophageal Carcinoma
  • Pancreatic Cancer
  • Prostate Cancer
  • Gastric Cancer
  • Hepatic Carcinoma

Interventions

DrugSynonymsArms
CAR-T cell immunotherapyCAR-T cell immunotherapy

Purpose

The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.

Detailed Description

      This study is being conducted to evaluate the safety and efficacy of Chimeric antigen
      receptor (CAR) T cells targeting EpCAM in treating patients with EpCAM positive cancer. In
      the research, the investigators design a novel CAR consists of a EpCAM targeting antibody
      scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T
      cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell
      infusion, the patients will be subjected to preconditioning treatment. The infusion dose is
      (1-10)×106 EpCAM-CAR positive T cells/kg, and the specific cells numbers depends on the
      situation of individual CAR-T cells preparation. The way of infusion is vascular
      interventional mediated or endoscopy, and the cells perfusion process would lasts 15min to
      30min, and the specific time depends on patent's tumor-burdened state. After T cell infusion,
      the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T
      cells and efficacy.
    

Trial Arms

NameTypeDescriptionInterventions
CAR-T cell immunotherapyExperimentalEnrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Relapsed or refractory EpCAM positive cancer.
    
              2. KPS > 60.
    
              3. Life expectancy>3 months.
    
              4. Gender unlimited, age from 18 years to 80 years.
    
              5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.
    
              6. Acceptable organ function Hematology:
    
                   -  Absolute neutrophil count greater than 800/mm^3 without the support of
                      filgrastim.
    
                   -  White blood cell (WBC) (> 2000/mm^3).
    
                   -  Platelet count greater than 50,000/mm^3.
    
                   -  Hemoglobin greater than 9.0 g/dl.
    
              7. No other serious diseases(autoimmune disease, immunodeficiency etc.).
    
              8. Adequate cardiac function (LVEF ≥ 40%).
    
              9. No other tumors.
    
             10. Patients volunteer to participate in the research.
    
            Exclusion Criteria:
    
              1. Allergic to cytokines.
    
              2. Uncontrolled active infection.
    
              3. Acute or chronic GVHD.
    
              4. MODS.
    
              5. Treated with T cell inhibitor.
    
              6. HIV affected.
    
              7. Pregnancy.
          
    Maximum Eligible Age:80 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
    Time Frame:up to 24 months
    Safety Issue:
    Description:Observe and handle the toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

    Secondary Outcome Measures

    Measure:Survival time of anti-EpCAM CAR T cells in vivo
    Time Frame:up to 24 months
    Safety Issue:
    Description:Detect the existence of CAR-T cells in the blood of participants through flow cytometry
    Measure:Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
    Time Frame:up to 24 months
    Safety Issue:
    Description:Anti-tumor efficacy of CAR-T therapy for patients with EpCAM positive cancers was assessed by RECIST v1.1

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:First Affiliated Hospital of Chengdu Medical College

    Last Updated

    January 4, 2017