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

Primary Purpose

Pancreatic Cancer, CAR

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Chimeric antigen receptor T cell

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, CAR-T, Mesothelin, CEA, HER2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR-T

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of patients with tumor response

Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary Outcome Measures

Number of patients with adverse event

Asverse event is evaluated with CTCAE, version 4.0

Full Information

NCT ID

NCT03267173

First Posted

August 27, 2017

Last Updated

August 27, 2017

Sponsor

First Affiliated Hospital of Harbin Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03267173

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 15, 2017 (Actual)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital of Harbin Medical University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, CAR

Keywords

Pancreatic Cancer, CAR-T, Mesothelin, CEA, HER2

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAR-T

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Chimeric antigen receptor T cell

Other Intervention Name(s)

meso-CAR

Intervention Description

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 Measure Information:

Title

Number of patients with tumor response

Description

Tumor response is assessmented with Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Number of patients with adverse event

Description

Asverse event is evaluated with CTCAE, version 4.0

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Yunwei, Dctor

Phone

86-85553099

hydwyw11@hotmall.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhao Lei, Dctor

Phone

86-13069890888

zhaoleihyd@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Yunwei, Dctor

Organizational Affiliation

First Affiliated Hospital of Harbin Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Harbin Medical University

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhao Lei, Doctor

Phone

86-13069890888

zhaoleihyd@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26931187

Citation

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.

Results Reference

background

PubMed Identifier

28634161

Citation

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.

Results Reference

background

PubMed Identifier

26503962

Citation

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.

Results Reference

background

PubMed Identifier

25584002

Citation

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.

Results Reference

background

PubMed Identifier

24694017

Citation

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.

Results Reference

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Links:

URL

http://www.ncbi.nlm.nih.gov

Description

References are all derived from PubMed

Learn more about this trial

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

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