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CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor:
Collaborators:
The First People's Hospital of Hefei
Hefei Binhu Hospital
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02617134
First received: November 26, 2015
Last updated: December 4, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.

Condition Intervention Phase
Malignant Glioma of Brain
Colorectal Carcinoma
Gastric Carcinoma
Biological: anti-MUC1 CAR-T cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunotherapy With Chimeric Antigen Receptor-Modified T Cells for MUC1 Positive Advanced Refractory Solid Tumor

Resource links provided by NLM:


Further study details as provided by PersonGen BioTherapeutics (Suzhou) Co., Ltd.:

Primary Outcome Measures:
  • Adverse events attributed to the administration of the anti-MUC1 CAR-T cells [ Time Frame: 2 years ]
    Determine the toxicity profile of the MUC1 targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-T infusion. ]
    The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.


Estimated Enrollment: 20
Study Start Date: November 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
Biological: anti-MUC1 CAR-T cells
Other Name: anti-MUC1-CAR transduced autologous T cells

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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+ malignant glioma of brain, colorectal carcinoma and gastric carcinoma.

    1a. Malignant Glioma of Brain Failure after previous standard of care initial treatment of glioblastoma multiforme; documentation by magnetic resonance imaging (MRI) of an interval increase in nodular gadolinium enhancement consistent with recurrent malignant glioma suitable for therapeutic re-resection; previous pathological diagnosis of World Health Organization (WHO) Grade IV glioma;

    1b. Colorectal Carcinoma Patients must have histologically proven adenocarcinoma primary to the colon or rectum and clinical or pathologic evidence of distant metastasis;

    1c. Gastric Carcinoma Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or esophagus; metastatic disease or locally advanced disease not amenable to curative surgery.

  • Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
  • MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
  • Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
  • 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 30% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02617134

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

Locations
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
Principal Investigator: Lin Yang, Ph.D. PersonGen BioTherapeutics (Suzhou) Co., Ltd.
  More Information

Responsible Party: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02617134     History of Changes
Other Study ID Numbers: PG-021-002
Study First Received: November 26, 2015
Last Updated: December 4, 2016

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Glioma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Stomach Diseases

ClinicalTrials.gov processed this record on April 24, 2017