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A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

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: NCT02713984
Recruitment Status : Unknown
Verified April 2016 by Zhi Yang, Southwest Hospital, China.
Recruitment status was:  Recruiting
First Posted : March 21, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Zhi Yang, Southwest Hospital, China

Brief Summary:
Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Lung Cancer Gastric Cancer Colorectal Cancer Glioma Pancreatic Cancer Biological: Anti-HER2 CAR-T Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
Study Start Date : March 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: HER2 positive cancers
Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells
Biological: Anti-HER2 CAR-T
HER-2-targeting CAR-T cells infusion in HER2 positive cancers




Primary Outcome Measures :
  1. Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. [ Time Frame: 3 years ]
    Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Secondary Outcome Measures :
  1. Survival time of Anti-HER2 CAR T cells in vivo. [ Time Frame: 1 year ]
    Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.

  2. Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells [ Time Frame: 12 weeks ]
    Evaluate the anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Related Response Criteria(iRECIST).

  3. Maximum tolerated dose (MTD) of HER2 targeted CAR T cells [ Time Frame: 4 weeks ]
    Determine the maximum tolerated dose of each participant through the grades of side effects.



Information from the National Library of Medicine

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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 HER2 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.

    Chemistry:

    • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
    • Serum creatinine less or equal to 3 times the upper limit of normal
    • Total bilirubin less than or equal to 3 times the upper limit of normal.
  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. Other situations improper for the research.

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): NCT02713984


Contacts
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Contact: Cheng Qian, MD,PhD 0086-023-68765461 cqian3184@163.com
Contact: Chengcheng Zhang, MD 0086-13883587876 zccszcg@163.com

Locations
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China, Chongqing
Southwest Hospital of Third Millitary Medical University Recruiting
Chongqing, Chongqing, China, 400000
Contact: Cheng Qian, MD,PhD    0086-023-68765461    cqian3184@163.com   
Contact: Chengcheng Zhang, MD    0086-13883587876    zccszcg@163.com   
Principal Investigator: Cheng Qian, MD,PhD         
Sub-Investigator: Zhi Yang, PhD         
Sub-Investigator: Chengcheng Zhang, MD         
Sponsors and Collaborators
Zhi Yang
Investigators
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Principal Investigator: Cheng Qian, MD,PhD Southwest Hospital, China

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Responsible Party: Zhi Yang, Researcher of Biotherpy Center, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02713984    
Other Study ID Numbers: TMMU-BTC-005
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zhi Yang, Southwest Hospital, China:
HER2 CAR-T
safety
efficiency
refractory and relapsed cancer