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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

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 6, 2017
Last Update Posted Date January 6, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
Official Title  ICMJE A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colon Cancer
  • Esophageal Carcinoma
  • Pancreatic Cancer
  • Prostate Cancer
  • Gastric Cancer
  • Hepatic Carcinoma
Intervention  ICMJE Biological: CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.
Study Arms  ICMJE 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.
Intervention: Biological: CAR-T cell immunotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03013712
Other Study ID Numbers  ICMJE CARTEPC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Chengdu Medical College
Study Sponsor  ICMJE First Affiliated Hospital of Chengdu Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xiao-an Li, PhD First Affiliated Hospital of Chengdu Medical College
PRS Account First Affiliated Hospital of Chengdu Medical College
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP