CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Glioma of Brain 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Clinical Trial Details — Status: Withdrawn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: NCT04406610
• Other study ID #: CAR-T
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 1, 2015
• Est. completion date: October 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 safty and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence

• Body tumor 1-6, the maximum tumor length < 2 cm

• KPS = 70, lifespan > 6 months

• Platelet count = 80×109/L,white blood cell count = 3×109/L, neutrophil count = 2×109/L, hemoglobin = 80 g/L

Exclusion Criteria:

• Patients with cardiac pacemaker

• Patients with brain metastasis

• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Related Conditions & MeSH terms

• CAR-T Cell Immunotherapy
• Glioma
• Glioma of Brain

Intervention

Biological:
• GD2 CAR-T immunotherapy
Antigen-specific T cell therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of adverse reactions	To observe the common 1-4 levels of side effects	3 months
Secondary	Progression free survival (PFS)of patients	PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.	1 year