Clinical trial NCT02713984: A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
Official title: A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Ovarian Cancer
Lung Cancer
Gastric Cancer
Colorectal Cancer
Glioma
Pancreatic Cancer
Keywords: HER2 CAR-T
safety
efficiency
refractory and relapsed cancer
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
timeFrame: 3 years
Secondary outcomes:
measure: Survival time of Anti-HER2 CAR T cells in vivo.
timeFrame: 1 year
measure: Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells
timeFrame: 12 weeks
measure: Maximum tolerated dose (MTD) of HER2 targeted CAR T cells
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital of Third Millitary Medical University
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Cheng Qian, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: