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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Recruitment Status : Withdrawn (Project terminated due to revision of local regulations)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

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.

Condition or disease Intervention/treatment Phase
Glioma of Brain CAR-T Cell Immunotherapy Biological: GD2 CAR-T immunotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Chimeric Antigen Receptor-Modified T Cells for GD2 Positive Recurrent and Metastatic Glioma
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : October 15, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GD2 CAR-T
Treated by GD2 CAR-T therapy intravenously
Biological: GD2 CAR-T immunotherapy
Antigen-specific T cell therapy
Other Name: CAR-T for glioma

No Intervention: Control
With no medical intervention



Primary Outcome Measures :
  1. Classification of adverse reactions [ Time Frame: 3 months ]
    To observe the common 1-4 levels of side effects


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT04406610    
Other Study ID Numbers: CAR-T
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Keywords provided by Fuda Cancer Hospital, Guangzhou:
CAR-T cell immunotherapy
GD2
glioma
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue