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WithdrawnNCT04406610Updated Jul 16, 2020

CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

A Phase 1/2 interventional study of GD2 CAR-T immunotherapy in Glioma of Brain and CAR-T Cell Immunotherapy, sponsored by Fuda Cancer Hospital, Guangzhou. Withdrawn. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-16.

Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Project terminated due to revision of local regulations

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Sep 2015, registered Sep 2019).
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Glioma of Brain
  • CAR-T Cell Immunotherapy

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Keywords

  • CAR-T cell immunotherapy
  • GD2
  • glioma
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

Browse Glioma studies →

Lead sponsor

Fuda Cancer Hospital, Guangzhou is the lead sponsor of 113 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    GD2 CAR-T

    Treated by GD2 CAR-T therapy intravenously

    Biological: GD2 CAR-T immunotherapy

  • No intervention
    Control

    With no medical intervention

Interventions

  • BiologicalGD2 CAR-T immunotherapy

    Antigen-specific T cell therapy

    Also known as: CAR-T for glioma

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What researchers measure

Primary outcomes

  1. Classification of adverse reactions

    To observe the common 1-4 levels of side effects

    Time frame: 3 months

Secondary outcomes

  1. Progression free survival (PFS)of patients

    PFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04406610
Lead sponsor
Fuda Cancer Hospital, Guangzhou
Responsible party
Sponsor
First posted
May 28, 2020
Start date
Sep 1, 2015
Primary completion
Aug 15, 2016
Completion
Oct 15, 2016
Last update
Jul 16, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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