Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Pancreatic Cancer Liver Cancer Gallbladder Cancer Bowel Cancer Drug: Recombinant Human Interleukin-2 Drug: HER2Bi-Armed T Cells Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
Study Start Date : February 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aldesleukin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: Recombinant Human Interleukin-2
Given SC
Other Names:
  • Proleukin
  • Recombinant Human IL-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.
 Drug: HER2Bi-Armed T Cells
Given IV
Other Name: HER2Bi-Armed ATCs


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Safety as measured by local and systemic toxicities [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02662348


Locations
Layout table for location information
China, Jiangsu
Nanjing, Jiangsu, China
Sponsors and Collaborators
Yi Miao
Nanjing Abingen Biotech Co. Ltd
Investigators
Layout table for investigator information
Principal Investigator: Yi Miao, PH.D The First Affiliated Hospital with Nanjing Medical University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Yi Miao, Director of the Pancreas Research Centre; Director of Institute of Tumor Biology, Jiangsu Province Academy of Clinical Medicine, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02662348    
Other Study ID Numbers: 2013-SR-116.F1
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Nov 2017 ( Anticipated)
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Gallbladder Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases
Aldesleukin
 Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents