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

  • days left to enroll
  • participants needed
  • sponsor
    Xuanwu Hospital, Beijing
Updated on 26 February 2022
growth factor
karnofsky performance status
malignant glioma


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, IL13R2, Her-2, EphA2, CD133, GD2).

Condition Glioma, Malignant Glioma of Brain, Recurrence Tumor
Treatment Chimeric antigen receptor T cells
Clinical Study IdentifierNCT03423992
SponsorXuanwu Hospital, Beijing
Last Modified on26 February 2022


Yes No Not Sure

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, IL13R2, 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
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
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
Serum creatinine less than or equal to 1.5 x upper limit of normal
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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