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Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas

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ClinicalTrials.gov Identifier: NCT03423992
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
Beijing Mario Biotech Company
Hebei Senlang BIotech Company
Beijing HuiNengAn Biotech Company
Information provided by (Responsible Party):
Qingtang Lin, Xuanwu Hospital, Beijing

Study Description
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Brief Summary:
A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor with or without anti-PDL1 antibody) personalized immunotherapy for patients with recurrent malignant gliomas based on the expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133, GD2).

Condition or disease Intervention/treatment Phase
Glioma Malignant Glioma of Brain Recurrence Tumor Biological: chimeric antigen receptor T cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety and Efficacy of Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas Based on the Expression of Tumor Specific/Associated Antigens
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Biological: Chimeric antigen receptor T cells Biological: chimeric antigen receptor T cells
chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events attributed to the administration of the chimeric antigen receptor T cells [ Time Frame: 1 year ]
    Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 1 year ]
    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.

  2. clinical activity of chimeric antigen receptor T cells [ Time Frame: 28 days ]
    the number of infused chimeric antigen receptor T cells;


Eligibility Criteria
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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:

  • Voluntary informed consent for entry of trial;
  • Age greater than 18 years, and less than 70 years;
  • Pathologically confirmed recurrent malignant gliomas;
  • Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;
  • If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.
  • Patients must have a Karnofsky performance status of greater than or equal to 70.
  • Life expectancy greater than 3 months;

  • Participants with adequate organ function as measured by:

    1. White blood count greater than or equal to 2500/mm^3; platelets greater than or equal to 100,000/mm^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support
    2. Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL
    3. Serum creatinine less than or equal to 1.5 x upper limit of normal
    4. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.

Exclusion Criteria:

  • Female subjects of reproductive potential who are pregnant or lactating;
  • Previous treatment with any gene therapy products or other form immunotherapy;
  • Uncontrolled active infection.
  • Active or latent chronic hepatitis B [detectable hepatitis B surface antigen (HBsAg)] or active hepatitis C (positive serology [hepatitis C virus Ab]) infection.
  • HIV infection;
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);
  • Currently enrolled in other clinical trials;
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): NCT03423992


Locations
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China
Xuanwu Hospital Recruiting
Beijing, China, 100054
Contact: Xinyan You, BA    8610-83198990    braintumortrail@163.com   
Contact: Qingtang Lin, M.D., Ph.D.    8610-83198362    linqingtang@xwhosp.org   
Principal Investigator: Qingtang Lin, M.D., Ph.D.         
Principal Investigator: Feng Ling, M.D., Ph.D.         
Sub-Investigator: Geng Xu, M.D.         
Sub-Investigator: Teer Ba, M.D.         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Beijing Mario Biotech Company
Hebei Senlang BIotech Company
Beijing HuiNengAn Biotech Company
More Information
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Responsible Party: Qingtang Lin, Associate Professor, Department of Neurosurgery, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03423992    
Other Study ID Numbers: Xuanwu hospital
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Recurrence
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes