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Chimeric Antigen Receptor-Modified T Cells for Breast Cancer

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ClinicalTrials.gov Identifier: NCT02547961
Recruitment Status : Withdrawn (Project terminated due to revision of local regulations)
First Posted : September 14, 2015
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of HER2-CAR-T cell Infusion for advanced HER2 positive breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: HER-2-targeting CAR T Cells infusion Phase 1 Phase 2

Detailed Description:
By enrolling patients with advanced HER2 positive breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HER2-CAR-T cell infusion for advanced HER2 positive breast cancer.The CAR consists of a HER-2 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 retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chimeric Antigen Receptor-Modified T Cells for HER-2 Positive Recurrent and Metastatic Breast Cancer
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : August 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: HER2-CAR-T
In interventional studies, participants are assigned to accept HER-2-targeting CAR T Cells infusion so that researchers can evaluate the effects and safety of the CAR-T cell.
 Biological: HER-2-targeting CAR T Cells infusion
HER-2-targeting CAR t cells infusion in breast cancer
No Intervention: No Intervention


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Adverse events [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. Tumor load [ Time Frame: 24weeks ]
    Tumor load will be quantified with radiology, bone marrow and/or blood


Other Outcome Measures:
  1. Progress free disease (PFS) [ Time Frame: 1 year ]
  2. Overall survival (OS) [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chemotherapy refractory Her2 positive breast cancer；
  2. Relapsed patients after anti-Her2 using antibody or kinase inhibitor therapy；
  3. Patients must be 18 years of age or older；
  4. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2；
  5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:

Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).

Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).

  • Seronegative for HIV antibody.
  • Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
  • Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
  • Patients must be willing to sign an informed consent.

Exclusion Criteria:

  • 1. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.

    2.Patients with any of the follo wing pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.

    3.Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.

    4.Pregnant and/or lactating women will be excluded. 5.Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.

    6.Patients with any type of primary immunodeficiencies will be excluded from the study.

    7.Patients requiring corticosteroids (other than inhaled) will be excluded. 8.Patients with history of T cell tumors will be excluded. 9.Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Contacts and Locations
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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): NCT02547961


Locations
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China, Guangdong
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PhD Fuda Cancer Hospital
More Information
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02547961    
Other Study ID Numbers: Breast Cancer CAR-T 001
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by Fuda Cancer Hospital, Guangzhou:
breast cancer
HER2
CAR-T cell
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases