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Phase I/II Study of Anti-Mucin1 (MUC1) CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02587689
Recruitment Status : Unknown
Verified December 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : October 27, 2015
Last Update Posted : December 5, 2016
Sponsor:
Collaborators:
The First People's Hospital of Hefei
Hefei Binhu Hospital
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients with relapsed or refractory solid tumor.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Non-small Cell Lung Cancer Pancreatic Carcinoma Triple-Negative Invasive Breast Carcinoma Biological: anti-MUC1 CAR T Cells Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Anti-MUC1 CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: anti-MUC1 CAR T Cells
The subject's T cells will be modified in one or two different ways that will allow the cells to identify and kill the MUC1+ tumor cells.
 Biological: anti-MUC1 CAR T Cells
Other Name: anti-MUC1-CAR transduced autologous T cells


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR T cells [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female subjects with MUC1+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:

  • Eligible diseases: MUC1+ hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma and triple-negative basal-like breast carcinoma.

    1. Hepatocellular carcinoma (HCC)

      Clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients;

    2. Non-small cell lung cancer

      Refractory or recurrent histologically or cytologically confirmed; unresectable; non-squamous NSCLC must have been tested for epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) translocation and if positive should have received appropriate tyrosine kinase inhibitor therapy prior to enrollment;

    3. Pancreatic carcinoma

      Patients with histologic verification of carcinoma of the pancreas (T1-3, N0-1) who have undergone surgical resection within the past 4 - 12 weeks. Patients with R1 resections are excluded;

    4. Triple-negative basal-like breast carcinoma

      Patients with basal-like breast carcinoma must have confirmed triple negative (estrogen receptor negative [ER-]/ progesterone receptor (PR) negative [PR-]/ human epidermal growth factor receptor-2 (HER2) negative [HER2-]) .

  • MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
  • Eastern cooperative oncology group (ECOG) performance status of 0-1 or karnofsky performance status (KPS) score is higher than 60.
  • Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
  • Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
  • Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR T cells.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
  • Ability to give informed consent.

Exclusion Criteria:

  • The transduction efficiency of the T cells is less than 10% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
  • Patients with symptomatic central nervous system (CNS) involvement.
  • Pregnant or nursing women may not participate.
  • Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
  • History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  • Previously treatment with any gene therapy products.
  • The existence of unstable or active ulcers or gastrointestinal bleeding.
  • Patients with portal vein vascular invasion or extrahepatic, are excluded from this study.
  • Patients with a history of organ transplantation or are waiting for organ transplantation.
  • Patients need anticoagulant therapy (such as warfarin or heparin).
  • Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
  • Patients treated by radiotherapy within 4 weeks prior the first apheresis.
  • Patients using fludarabine or cladribine chemotherapy within two years.
Contacts and Locations
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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): NCT02587689


Contacts
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Contact: Lin Yang, Ph.D. 86-512-65922190 lin.yang@persongen.com

Locations
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China, Jiangsu
PersonGen Biomedicine (Suzhou) Co., Ltd. Recruiting
Suzhou, Jiangsu, China, 215123
Contact: Lin Yang, Ph.D.    86-512-65922190    lin.yang@persongen.com   
Principal Investigator: Yangyi Bao, MD         
Principal Investigator: Xiang Sun, MD         
Principal Investigator: Lin Yang, Ph.D.         
Sponsors and Collaborators
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
The First People's Hospital of Hefei
Hefei Binhu Hospital
Investigators
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Principal Investigator: Lin Yang, Ph.D. PersonGen BioTherapeutics (Suzhou) Co., Ltd.
More Information
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Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02587689    
Other Study ID Numbers: PG-021-001
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
 Digestive System Neoplasms
Digestive System Diseases
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases