Clinical Trials /

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

NCT03423992

Description:

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).

Related Conditions:
  • Malignant Glioma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
  • 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

Clinical Trial IDs

  • ORG STUDY ID: Xuanwu hospital
  • NCT ID: NCT03423992

Conditions

  • Glioma
  • Malignant Glioma of Brain
  • Recurrence Tumor

Interventions

DrugSynonymsArms
chimeric antigen receptor T cellsBiological: Chimeric antigen receptor T cells

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Biological: Chimeric antigen receptor T cellsExperimental
  • chimeric antigen receptor T cells

Eligibility 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;
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse events attributed to the administration of the chimeric antigen receptor T cells
Time Frame:1 year
Safety Issue:
Description: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

Measure:Objective Response Rate
Time Frame:1 year
Safety Issue:
Description: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.
Measure:clinical activity of chimeric antigen receptor T cells
Time Frame:28 days
Safety Issue:
Description:the number of infused chimeric antigen receptor T cells;

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Xuanwu Hospital, Beijing

Last Updated

December 16, 2019