A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
NCT ID: NCT02713984
Last Updated: 2020-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2016-03-31
2019-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HER2 positive cancers
Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells
Anti-HER2 CAR-T
HER-2-targeting CAR-T cells infusion in HER2 positive cancers
Interventions
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Anti-HER2 CAR-T
HER-2-targeting CAR-T cells infusion in HER2 positive cancers
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Zhi Yang
OTHER
Responsible Party
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Zhi Yang
Researcher of Biotherpy Center
Principal Investigators
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Cheng Qian, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Southwest Hospital, China
Locations
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Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, China
Countries
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Other Identifiers
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TMMU-BTC-005
Identifier Type: -
Identifier Source: org_study_id
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