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CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

Primary Purpose

GD2 Positive Glioma, CAR-T Cell Immunotherapy

Status

Withdrawn

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CAR-T cell immunotherapy

About this trial

This is an interventional treatment trial for GD2 Positive Glioma focused on measuring CAR-T cell immunotherapy, GD2, glioma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The primary GD2 positive patients, the best are glioma patients.
The recurrent GD2 positive patients, the best are glioma patients.
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.
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.
Patients must be willing to sign an informed consent.

Exclusion Criteria:

The patients with multiple kinds of cancers are excluded.
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.
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.
Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
Pregnant and/or lactating women will be excluded.
Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
Patients with any type of primary immunodeficiencies will be excluded from the study.
Patients requiring corticosteroids (other than inhaled) will be excluded.
Patients with history of T cell tumors will be excluded.
Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Sites / Locations

Central laboratory in Fuda cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental: CAR-T cell immunotherapy

No Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

The effectiveness of CAR-T cell immunotherapy

It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Secondary Outcome Measures

Progress free survival（PFS）

Full Information

NCT ID

NCT03252171

First Posted

October 18, 2015

Last Updated

July 14, 2020

Sponsor

Fuda Cancer Hospital, Guangzhou

1. Study Identification

Unique Protocol Identification Number

NCT03252171

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Project terminated due to revision of local regulations

Study Start Date

October 15, 2015 (Actual)

Primary Completion Date

August 15, 2016 (Actual)

Study Completion Date

August 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuda Cancer Hospital, Guangzhou

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GD2 Positive Glioma, CAR-T Cell Immunotherapy

Keywords

CAR-T cell immunotherapy, GD2, glioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: CAR-T cell immunotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

No Intervention

Arm Type

No Intervention

Intervention Type

Biological

Intervention Name(s)

CAR-T cell immunotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

The effectiveness of CAR-T cell immunotherapy

Description

It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Progress free survival（PFS）

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Overall survival（OS）

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The primary GD2 positive patients, the best are glioma patients. The recurrent GD2 positive patients, the best are glioma patients. 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. 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. Patients must be willing to sign an informed consent. Exclusion Criteria: The patients with multiple kinds of cancers are excluded. 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. 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. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded. Pregnant and/or lactating women will be excluded. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors. Patients with any type of primary immunodeficiencies will be excluded from the study. Patients requiring corticosteroids (other than inhaled) will be excluded. Patients with history of T cell tumors will be excluded. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lizhi Niu, PhD

Organizational Affiliation

Fuda Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Central laboratory in Fuda cancer hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

12. IPD Sharing Statement

Learn more about this trial

CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

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