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CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406610
Recruitment Status : Withdrawn (Project terminated due to revision of local regulations)
First Posted : May 28, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

Tracking Information
First Submitted Date  ICMJE September 10, 2019
First Posted Date  ICMJE May 28, 2020
Last Update Posted Date July 16, 2020
Actual Study Start Date  ICMJE September 1, 2015
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2020)
Classification of adverse reactions [ Time Frame: 3 months ]
To observe the common 1-4 levels of side effects
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2020)
Adverse effects [ Time Frame: 3 months ]
To observe the common 1-4 levels of side effects
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2020)
Progression free survival (PFS)of patients [ Time Frame: 1 year ]
PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2020)
PFS [ Time Frame: 1 year ]
PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients
Official Title  ICMJE Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
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 safty and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma of Brain
  • CAR-T Cell Immunotherapy
Intervention  ICMJE Biological: GD2 CAR-T immunotherapy
Antigen-specific T cell therapy
Other Name: CAR-T for glioma
Study Arms  ICMJE
  • Experimental: GD2 CAR-T
    Treated by GD2 CAR-T therapy intravenously
    Intervention: Biological: GD2 CAR-T immunotherapy
  • No Intervention: Control
    With no medical intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 14, 2020)
0
Original Actual Enrollment  ICMJE
 (submitted: May 24, 2020)
2
Actual Study Completion Date  ICMJE October 15, 2016
Actual Primary Completion Date August 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04406610
Other Study ID Numbers  ICMJE CAR-T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fuda Cancer Hospital, Guangzhou
Study Sponsor  ICMJE Fuda Cancer Hospital, Guangzhou
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fuda Cancer Hospital, Guangzhou
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP