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Evaluate the Safety and Efficacy of CAR-T in the Treatment of Pancreatic Cancer.

This study is currently recruiting participants.
Verified August 2017 by First Affiliated Hospital of Harbin Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03267173
First Posted: August 30, 2017
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University
August 27, 2017
August 30, 2017
August 30, 2017
June 15, 2017
June 2019   (Final data collection date for primary outcome measure)
Number of patients with tumor response [ Time Frame: 8 weeks ]
Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Same as current
No Changes Posted
Number of patients with adverse event [ Time Frame: 8 weeks ]
Asverse event is evaluated with CTCAE, version 4.0
Same as current
Not Provided
Not Provided
 
Evaluate the Safety and Efficacy of CAR-T in the Treatment of Pancreatic Cancer.
Evaluate the Safety and Efficacy of Chimeric Antigen Receptor Engineered T Cell Immunotherapy (CAR-T) in the Treatment of Pancreatic Cancer in a Single Center, Non Controlled Clinical Study.
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. It has become the fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy, radiotherapy) . Mesothelin, PSCA, CEA, HER2, MUC1 and EGFRvIII are potential targets and spectacular paradigm in the diagnosis and treatment of pancreatic cancer. This study is for evaluation of the safety and efficacy of Mesothelin, PSCA, CEA, HER2, MUC1, EGFRvIII targeted and other CAR-T cell immunotherapy for pancreatic cancer.
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. It has become the fourth tumor treatment model after traditional tumor therapies (surgery, chemotherapy, radiotherapy) . With the development of the research field, the CAR-T cell basis and clinical research of various targets have achieved good results. Mesothelin, PSCA, CEA, HER2, MUC1 and EGFRvIII are potential targets and spectacular paradigm in the diagnosis and treatment of pancreatic cancer. This study is for evaluation of the safety and efficacy of Mesothelin, PSCA, CEA, HER2, MUC1, EGFRvIII targeted and other CAR-T cell immunotherapy for pancreatic cancer.
Interventional
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pancreatic Cancer
  • CAR
Drug: Chimeric antigen receptor T cell
Evaluate the efficacy and safety of targeted Mesothelin/PSCA/CEA/HER2/MUC1/, EGFRvIII and other chimeric antigen receptor engineered T cell immunotherapy in the treatment of pancreatic cancer.
Other Name: meso-CAR
Experimental: CAR-T
A single dose of Chimeric antigen receptor T cells will be administered by vascular interventional mediated as one dose infusions. According to the patient's condition and weight, the intervention dose of aE7 CAR-T cells per kilogram of body weight was treated once.
Intervention: Drug: Chimeric antigen receptor T cell

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2019
June 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Imaging, pathology or biopsy confirmed as pancreatic cancer and it has metastasized, can not radical cured by surgery; patients restored good but there is still residual lesions, recurrence or metastasis 1 months after surgery;
  • Accepted more than 1 times chemotherapy which is invalid or unwilling to accept previous chemotherapy patients;
  • The corresponding antigens such as Meso and PSCA/ CEA/ HER2/ MUC1/ EGFRvIII were highly expressed;
  • Male patients aged between 18 and 65;
  • Life expectancy greater than 1 months;
  • Karnofsky score ≥ 60, ECOG≤ 2;
  • Important organ function as defined by the following: cardiac ejection fraction ≥ 50%; electrocardiogram showed no obvious abnormalities; creatinine clearance rate calculated by using Cockcroft- Gault formula ≥40ml/min ; ALT/AST≤ 3×the institution normal upper limit; total bilirubin ≤2.0mg/dl; coagulation function: PT/ APPT<2 ×the institution normal upper limit; SpO2 >92%; Blood: hemoglobin>80g/L, ANC ≥ 1, PLT ≥ 50×109/L;
  • There is measurable target lesion;
  • Voluntary informed consent is given.

Exclusion Criteria:

  • Immunosuppressive drugs or hormones were used a week before admission;
  • Severe active infection;
  • Human immunodeficiency virus (HIV) positive;
  • Active hepatitis B or C infection;
  • Past medical history of other malignancies. Not included: patients who have been cured at any time prior to the treatment of the skin basal or squamous cell carcinoma and cervical carcinoma in situ; the other tumor has not listed above, but has been used and only cured by surgery, without further treatment by other measures, the subjects of disease-free survival more than 5 years, can be included in the study;
  • Patients participating in other clinical trials;
  • The researchers thought the subjects were unfit for inclusion or unable to participate in or complete the study;
  • Patients with congenital immunodeficiency;
  • There is a history of myocardial infarction and serious arrhythmia within six months.
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact: Wei Yunwei, Dctor 86-85553099 hydwyw11@hotmall.com
Contact: Zhao Lei, Dctor 86-13069890888 zhaoleihyd@163.com
China
 
 
NCT03267173
Yunwei Wei
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Harbin Medical University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Study Director: Wei Yunwei, Dctor First Affiliated Hospital of Harbin Medical University
First Affiliated Hospital of Harbin Medical University
August 2017

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