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CAR-T Cell Immunotherapy in MUC1 Positive 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. Identifier: NCT02617134
Recruitment Status : Unknown
Verified July 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 30, 2015
Last Update Posted : December 6, 2016
The First People's Hospital of Hefei
Hefei Binhu Hospital
Information provided by (Responsible Party):
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 26, 2015
First Posted Date  ICMJE November 30, 2015
Last Update Posted Date December 6, 2016
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor
Official Title  ICMJE Immunotherapy With Chimeric Antigen Receptor-Modified T Cells for MUC1 Positive Advanced Refractory Solid Tumor
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Glioma of Brain
  • Colorectal Carcinoma
  • Gastric Carcinoma
Intervention  ICMJE Biological: anti-MUC1 CAR-T cells
Other Name: anti-MUC1-CAR transduced autologous T cells
Study Arms  ICMJE 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.
Intervention: Biological: anti-MUC1 CAR-T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 26, 2015)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02617134
Other Study ID Numbers  ICMJE PG-021-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study Sponsor  ICMJE PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators  ICMJE
  • The First People's Hospital of Hefei
  • Hefei Binhu Hospital
Investigators  ICMJE
Principal Investigator: Lin Yang, Ph.D. PersonGen BioTherapeutics (Suzhou) Co., Ltd.
PRS Account PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP