Clinical trialPhase 1 / Phase 2Withdrawn
A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
- Outcome
- Stopped earlyReform CAR structure due to safety consideration (Toxicity)
- Cell product
- CAR-T cells
A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
- Target antigen
- HER2
A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
- Phase
- Phase 1 / Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Planned start
- March 2016
- Planned end
- July 2019
- Enrollment
- 0 participants
- Sites
- 1
- Primary outcomes
- Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 19 March 2020
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Biological: Anti-HER2 CAR-T. HER-2-targeting CAR-T cells infusion in HER2 positive cancers
Arm public domain (ClinicalTrials.gov)
HER2 positive cancers (experimental): Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells
Eligibility public domain (ClinicalTrials.gov)
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.