Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
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
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2018
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedStudy Start
First participant enrolled
March 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedJune 15, 2021
June 1, 2021
4.9 years
January 22, 2018
June 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events attributed to the administration of the chimeric antigen receptor T cells
Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
1 year
Secondary Outcomes (2)
Objective Response Rate
1 year
clinical activity of chimeric antigen receptor T cells
28 days
Study Arms (1)
Biological: Chimeric antigen receptor T cells
EXPERIMENTALInterventions
chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively
Eligibility Criteria
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuanwu Hospital, Beijinglead
- Beijing Mario Biotech Companycollaborator
- Hebei Senlang BIotech Companycollaborator
- Beijing HuiNengAn Biotech Companycollaborator
Study Sites (1)
Xuanwu Hospital
Beijing, 100054, China
Related Publications (1)
Lin Q, Ba T, Ho J, Chen D, Cheng Y, Wang L, Xu G, Xu L, Zhou Y, Wei Y, Li J, Ling F. First-in-Human Trial of EphA2-Redirected CAR T-Cells in Patients With Recurrent Glioblastoma: A Preliminary Report of Three Cases at the Starting Dose. Front Oncol. 2021 Jun 21;11:694941. doi: 10.3389/fonc.2021.694941. eCollection 2021.
PMID: 34235085DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Neurosurgery
Study Record Dates
First Submitted
January 22, 2018
First Posted
February 6, 2018
Study Start
March 2, 2018
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
June 15, 2021
Record last verified: 2021-06