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A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer (CARTEPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013712
Recruitment Status : Unknown
Verified January 2017 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was:  Recruiting
First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Chengdu Medical College

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

Condition or disease Intervention/treatment Phase
Colon Cancer Esophageal Carcinoma Pancreatic Cancer Prostate Cancer Gastric Cancer Hepatic Carcinoma Biological: CAR-T cell immunotherapy Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Biological: CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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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): NCT03013712


Contacts
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Contact: Yan Zhou, PhD +86-18981941992 zqlvzy319@163.com

Locations
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China
IEC of Chengdu Medical College Recruiting
Chendu, China, 610500
Contact: Xiao-an Li, post doctor    +8613680868858    435445611@qq.com   
Sponsors and Collaborators
First Affiliated Hospital of Chengdu Medical College
Investigators
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Study Chair: Xiao-an Li, PhD First Affiliated Hospital of Chengdu Medical College
More Information
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Responsible Party: First Affiliated Hospital of Chengdu Medical College
ClinicalTrials.gov Identifier: NCT03013712    
Other Study ID Numbers: CARTEPC-001
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Esophageal Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
 Digestive System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Adenocarcinoma
Liver Neoplasms
Liver Diseases