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

August 27, 2017 updated by: First Affiliated Hospital of Harbin Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • Harbin Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • meso-CAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse event
Time Frame: 8 weeks
Asverse event is evaluated with CTCAE, version 4.0
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Investigators

  • Study Director: Wei Yunwei, Dctor, First Affiliated Hospital of Harbin Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2017

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

August 27, 2017

First Submitted That Met QC Criteria

August 27, 2017

First Posted (ACTUAL)

August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 27, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yunwei Wei

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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