Evaluate The Safety And Efficacy Of CAR-T In The Treatment Of Pancreatic Cancer.

Study Overview

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

Pancreatic Cancer
CAR

DRUG: Chimeric antigen receptor T cell

Yunwei Wei

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-08-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-08-27
First Submitted that Met QC Criteria 2017-08-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-08-30
First Posted (ACTUAL) 2017-08-30	Results First Posted N/A	Last Verified 2017-08

Study Plan

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

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 w	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.

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 w

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.

Primary Outcome Measures	Measure Description	Time Frame
Number of patients with tumor response	Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	8 weeks

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

Contacts and Locations

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

Study Contact

Name: Wei Yunwei, Dctor

Phone Number: 86-85553099

Email: [email protected]

Study Contact Backup

Name: Zhao Lei, Dctor

Phone Number: 86-13069890888

Email: [email protected]

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.

Ages Eligible for Study:
MALE

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

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

Investigators

STUDY_DIRECTOR: Wei Yunwei, Dctor, First Affiliated Hospital of Harbin Medical University

Publications

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

General Publications

Zervos E, Agle S, Freistaedter AG, Jones GJ, Roper RL. Murine mesothelin: characterization, expression, and inhibition of tumor growth in a murine model of pancreatic cancer. J Exp Clin Cancer Res. 2016 Mar 1;35:39. doi: 10.1186/s13046-016-0314-2.
Freedman JD, Hagel J, Scott EM, Psallidas I, Gupta A, Spiers L, Miller P, Kanellakis N, Ashfield R, Fisher KD, Duffy MR, Seymour LW. Oncolytic adenovirus expressing bispecific antibody targets T-cell cytotoxicity in cancer biopsies. EMBO Mol Med. 2017 Aug;9(8):1067-1087. doi: 10.15252/emmm.201707567.
Morello A, Sadelain M, Adusumilli PS. Mesothelin-Targeted CARs: Driving T Cells to Solid Tumors. Cancer Discov. 2016 Feb;6(2):133-46. doi: 10.1158/2159-8290.CD-15-0583. Epub 2015 Oct 26.
Le DT, Wang-Gillam A, Picozzi V, Greten TF, Crocenzi T, Springett G, Morse M, Zeh H, Cohen D, Fine RL, Onners B, Uram JN, Laheru DA, Lutz ER, Solt S, Murphy AL, Skoble J, Lemmens E, Grous J, Dubensky T Jr, Brockstedt DG, Jaffee EM. Safety and survival with GVAX pancreas prime and Listeria Monocytogenes-expressing mesothelin (CRS-207) boost vaccines for metastatic pancreatic cancer. J Clin Oncol. 2015 Apr 20;33(12):1325-33. doi: 10.1200/JCO.2014.57.4244. Epub 2015 Jan 12.
Abate-Daga D, Lagisetty KH, Tran E, Zheng Z, Gattinoni L, Yu Z, Burns WR, Miermont AM, Teper Y, Rudloff U, Restifo NP, Feldman SA, Rosenberg SA, Morgan RA. A novel chimeric antigen receptor against prostate stem cell antigen mediates tumor destruction in a humanized mouse model of pancreatic cancer. Hum Gene Ther. 2014 Dec;25(12):1003-12. doi: 10.1089/hum.2013.209.

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Clinical Trial Record