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T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

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: NCT02662348
Recruitment Status : Unknown
Verified January 2016 by Yi Miao, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Collaborator:
Nanjing Abingen Biotech Co. Ltd
Information provided by (Responsible Party):
Yi Miao, The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE January 20, 2016
First Posted Date  ICMJE January 25, 2016
Last Update Posted Date January 25, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
Safety as measured by local and systemic toxicities [ Time Frame: Up to 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2016)
  • Changes in cytokine profiles and tumor markers in serum before and after treatment [ Time Frame: Baseline to up to 12 months ]
    Increases or decreases in the amount of cytokine produced from the pre-immunotherapy baseline at any time point after immunotherapy will be considered as continuous outcomes.
  • Changes in phenotyping induced by immunotherapy in peripheral blood mononuclear cells (PBMC) [ Time Frame: Baseline to up to 12 months ]
    PBMC from the patients will be obtained before and after immunotherapy to determine if there are any phenotype changes induced by immunotherapy. Paired t-test will be used to compare the difference between baseline and after any time point of armed T cells treatment in T cell subpopulation (FACS), tumor marker (CBA/ELISA) and tumor killing ability of PBMC.
  • Clinical response rate (including clinical symptoms and signs, complete response, partial response, progressive disease, and stable disease, imaging examination of pretherapy and post-treatment) will be measured by follow-up investigation. [ Time Frame: Up to 12 months ]
    Point and exact confidence interval estimates will be calculated for response rate.
  • Overall survival [ Time Frame: Up to 12 months ]
    Will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 6 month, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates will be calculated.
  • Progression free survival [ Time Frame: From the beginning of immunotherapy to progression or death, assessed up to 12 months ]
    Will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 6 month, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates will be calculated.
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 T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
Official Title  ICMJE T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
Brief Summary This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.
Detailed Description

PRIMARY OBJECTIVES:

I. Perform a phase I clinical trial to clearly define the toxicity profile of IV HER2Bi armed T cells in patients with neoplasms of digestive system.

SECONDARY OBJECTIVES:

I. Evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory Her2 positive cancer cell lines.

II. Evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival.

OUTLINE: This is a safety study of IV infused HER2Bi-armed activated T cells. Patients receive HER2Bi armed T cells IV weekly for 4 weeks. Patients also receive low-dose Interleukin subcutaneously (SC) daily beginning 3 days before the first HER2Bi armed T cells infusion. Treatment continues in the absence of disease progression or unacceptable toxicity.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Gallbladder Cancer
  • Bowel Cancer
Intervention  ICMJE
  • Drug: Recombinant Human Interleukin-2
    Given SC
    Other Names:
    • Proleukin
    • Recombinant Human IL-2
  • Drug: HER2Bi-Armed T Cells
    Given IV
    Other Name: HER2Bi-Armed ATCs
Study Arms  ICMJE
  • Experimental: Interleukin-2 Transfusion
    Patients receive low-dose Recombinant Human Interleukin-2 SC daily beginning 3 days before the first HER2Bi armed T cell infusions infusion.
    Intervention: Drug: Recombinant Human Interleukin-2
  • Experimental: T Cells Transfusion
    Patients receive HER2Bi-Armed T Cells IV weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
    Intervention: Drug: HER2Bi-Armed T Cells
Publications *

*   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 20, 2016)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2017
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient with Her2-positive neoplasms of digestive system: IHC 3+
  2. Clinical staging: Phase III or above
  3. Ages: < 65
  4. Expected survival time: > 1 year
  5. Quality of Life: > 60
  6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal
  7. The volunteers with informed consent

Exclusion criteria:

  1. Patient with Her2-negative neoplasms of digestive system
  2. Hepatic renal dysfunction
  3. Cardiopulmonary insufficiency
  4. Mental disorder
  5. Allergic condition
  6. With other malignant tumor
  7. Lactating women
  8. Patients with infection or received chemotherapy in the past two weeks
  9. Patient with autoimmune disease using immunosuppressive drug
  10. Patient with organ transplantation with long term use of immunosupresive drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 NCT02662348
Other Study ID Numbers  ICMJE 2013-SR-116.F1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Nov 2017 ( Anticipated)
Responsible Party Yi Miao, The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE Yi Miao
Collaborators  ICMJE Nanjing Abingen Biotech Co. Ltd
Investigators  ICMJE
Principal Investigator: Yi Miao, PH.D The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date January 2016

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