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).
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
Drug | Synonyms | Arms |
---|
chimeric antigen receptor T cells | | Biological: 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
Name | Type | Description | Interventions |
---|
Biological: Chimeric antigen receptor T cells | Experimental | | - 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
June 15, 2021