CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

CAR-T Cell Immunotherapy Clinical Trial

Official title:

Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03252171
• Other study ID #: CAR-T for GD2 positive glioma
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: October 15, 2015
• Est. completion date: August 15, 2016

Study information

• Verified date: July 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Description:

Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor aiming at GD2 antigen. After CAR-T cell infusion, At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study, the investigators will evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The primary GD2 positive patients, the best are glioma patients.

2. The recurrent GD2 positive patients, the best are glioma patients.

3. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:

• Absolute neutrophil count greater than 1500/mm3.

• Platelet count greater than 100,000/mm3.

• Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).

• Total bilirubin < 1.5 times upper limits of normal.

• Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).

• Seronegative for HIV antibody.

• Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.

4. Patients must be willing to practice birth control during and for four months following treatment.

NOTE: women of child-bearing age must have evidence of negative pregnancy test.

5. Patients must be willing to sign an informed consent.

Exclusion Criteria:

1. The patients with multiple kinds of cancers are excluded.

2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.

3. Patients with any of the following pulmonary function abnormalities will be excluded:

FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.

4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.

5. Pregnant and/or lactating women will be excluded.

6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.

7. Patients with any type of primary immunodeficiencies will be excluded from the study.

8. Patients requiring corticosteroids (other than inhaled) will be excluded.

9. Patients with history of T cell tumors will be excluded.

10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Related Conditions & MeSH terms

• CAR-T Cell Immunotherapy
• GD2 Positive Glioma
• Glioma

Intervention

Biological:
• CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.

Locations

Country	Name	City	State
China	Central laboratory in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival(OS)		3 years
Primary	The effectiveness of CAR-T cell immunotherapy	It will be evaluated by the Response Evaluation Criteria in Solid Tumors(RECIST)	3 months
Secondary	Progress free survival(PFS)		1 year