Clinical trial NCT03252171: CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients
Official title: Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: GD2 Positive Glioma
CAR-T Cell Immunotherapy
Keywords: CAR-T cell immunotherapy
GD2
glioma
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effectiveness of CAR-T cell immunotherapy
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
Other outcomes:
measure: Overall survival（OS）
timeFrame: 3 years
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References: