CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

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

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

Study Overview

• Status: Withdrawn
• Conditions: GD2 Positive Glioma; CAR-T Cell Immunotherapy
• Intervention / Treatment: Biological: CAR-T cell immunotherapy

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Central laboratory in Fuda cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 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.	Biological: CAR-T cell immunotherapy; This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.
No Intervention: No Intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Progress free survival（PFS）	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Overall survival（OS）	3 years

Collaborators and Investigators

• Sponsor: Fuda Cancer Hospital, Guangzhou

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2015
• Primary Completion (Actual): August 15, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: October 18, 2015
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: glioma; CAR-T cell immunotherapy; GD2
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: CAR-T for GD2 positive glioma

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No