NCT03267173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at P25-P50 for early_phase_1 pancreatic-cancer

Timeline
Completed

Started Jun 2017

Shorter than P25 for early_phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

August 27, 2017

Last Update Submit

August 27, 2017

Conditions

Pancreatic CancerCAR

Keywords

Pancreatic CancerCAR-TMesothelinCEAHER2

Outcome Measures

Primary Outcomes (1)

  • Number of patients with tumor response

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

    8 weeks

Secondary Outcomes (1)

  • Number of patients with adverse event

    8 weeks

Study Arms (1)

CAR-T

EXPERIMENTAL

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

Interventions

Chimeric antigen receptor T cellDRUG

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.

Also known as: meso-CAR
CAR-T

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Patients with congenital immunodeficiency；
  • There is a history of myocardial infarction and serious arrhythmia within six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbin Medical University

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26931187BACKGROUND

  • 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.

    PMID: 28634161BACKGROUND

  • 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.

    PMID: 26503962BACKGROUND

  • 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.

    PMID: 25584002BACKGROUND

  • 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.

    PMID: 24694017BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Wei Yunwei, Dctor

    First Affiliated Hospital of Harbin Medical University

    STUDY DIRECTOR

Central Study Contacts

Wei Yunwei, Dctor

CONTACT

86-85553099hydwyw11@hotmall.com

Zhao Lei, Dctor

CONTACT

86-13069890888zhaoleihyd@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2017

First Posted

August 30, 2017

Study Start

June 15, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 30, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)