A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

  • Biological: CAR-T cell immunotherapy
    • This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.

Arms, Groups and Cohorts

  • Experimental: CAR-T cell immunotherapy
    • Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen by infusion.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital of Chengdu Medical College
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiao-an Li, PhD, Study Chair, First Affiliated Hospital of Chengdu Medical College
  • Overall Contact(s)
    • Yan Zhou, PhD, +86-18981941992, zqlvzy319@163.com

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