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CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients

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

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04406610
Enrollment
0
Registered
2020-05-28
Start date
2015-09-01
Completion date
2016-10-15
Last updated
2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CAR-T Cell Immunotherapy, Glioma of Brain

Keywords

CAR-T cell immunotherapy, GD2, 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.

Interventions

BIOLOGICALGD2 CAR-T immunotherapy

Antigen-specific T cell therapy

Sponsors

Fuda Cancer Hospital, Guangzhou
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
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

* Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Design outcomes

Primary

MeasureTime frameDescription
Classification of adverse reactions3 monthsTo observe the common 1-4 levels of side effects

Secondary

MeasureTime frameDescription
Progression free survival (PFS)of patients1 yearPFS was defined as the interval between treatment initiation and local relapse, distant metastasis, or death, whichever occurred first.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026