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

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Recruiting
CT.gov ID
NCT03423992
Collaborator
Beijing Mario Biotech Company (Other), Hebei Senlang BIotech Company (Other), Beijing HuiNengAn Biotech Company (Other)
100
Enrollment
1
Location
1
Arm
59
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: chimeric antigen receptor T cells
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 2, 2018
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Adverse events attributed to the administration of the chimeric antigen receptor T cells [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 [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 [28 days]

    the number of infused chimeric antigen receptor T cells;

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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/mm3; platelets greater than or equal to 100,000/mm3, 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

Locations

Site City State Country Postal Code
1 Xuanwu Hospital Beijing China 100054

Sponsors and Collaborators

  • Xuanwu Hospital, Beijing
  • Beijing Mario Biotech Company
  • Hebei Senlang BIotech Company
  • Beijing HuiNengAn Biotech Company

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qingtang Lin, Associate Professor, Department of Neurosurgery, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier:
NCT03423992
Other Study ID Numbers:
  • Xuanwu hospital
First Posted:
Feb 6, 2018
Last Update Posted:
Jun 15, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glioma
Recurrence

Study Results

No Results Posted as of Jun 15, 2021