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A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

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ClinicalTrials.gov Identifier: NCT02713984
Recruitment Status : Withdrawn (Reform CAR structure due to safety consideration)
First Posted : March 21, 2016
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Zhi Yang, Southwest Hospital, China

Tracking Information
First Submitted Date  ICMJE March 12, 2016
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date March 19, 2020
Study Start Date  ICMJE March 2016
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • 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.
  • 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).
  • 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.
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 HER2 Positive Cancer
Official Title  ICMJE A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
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.
Detailed Description Not Provided
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
  • Breast Cancer
  • Ovarian Cancer
  • Lung Cancer
  • Gastric Cancer
  • Colorectal Cancer
  • Glioma
  • Pancreatic Cancer
Intervention  ICMJE Biological: Anti-HER2 CAR-T
HER-2-targeting CAR-T cells infusion in HER2 positive cancers
Study Arms  ICMJE Experimental: HER2 positive cancers
Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells
Intervention: Biological: Anti-HER2 CAR-T
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 17, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
60
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 NCT02713984
Other Study ID Numbers  ICMJE TMMU-BTC-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhi Yang, Southwest Hospital, China
Study Sponsor  ICMJE Zhi Yang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cheng Qian, MD,PhD Southwest Hospital, China
PRS Account Southwest Hospital, China
Verification Date March 2020

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