CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Phase 1

Withdrawn

• Conditions: GD2 Positive Glioma; CAR-T Cell Immunotherapy
• Interventions: Biological: CAR-T cell immunotherapy

• Registration Number: NCT03252171
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-10-15
• Study First Submitted: 2015-10-18
• Primary Completion: 2016-08-15
• Study Completion: 2016-08-15
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: CAR-T cell immunotherapy	CAR-T cell immunotherapy	Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen by infusion.

Primary Outcome Measures

Name	Time	Method
The effectiveness of CAR-T cell immunotherapy	3 months	It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Name	Time	Method
Progress free survival（PFS）	1 year

Trial Locations

Locations (1)

Central laboratory in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China