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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
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer CAR Drug: Chimeric antigen receptor T cell Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital of Harbin Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of patients with adverse event [ Time Frame: 8 weeks ]
    Asverse event is evaluated with CTCAE, version 4.0


Estimated Enrollment: 10
Actual Study Start Date: June 15, 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT03267173


Contacts
Contact: Wei Yunwei, Dctor 86-85553099 hydwyw11@hotmall.com
Contact: Zhao Lei, Dctor 86-13069890888 zhaoleihyd@163.com

Locations
China, Heilongjiang
Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Zhao Lei, Doctor    86-13069890888    zhaoleihyd@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Investigators
Study Director: Wei Yunwei, Dctor First Affiliated Hospital of Harbin Medical University
  More Information

Additional Information:
Publications:

Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03267173     History of Changes
Other Study ID Numbers: Yunwei Wei
First Submitted: August 27, 2017
First Posted: August 30, 2017
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:
Pancreatic Cancer
CAR-T
Mesothelin
CEA
HER2

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases