RecruitingEarly Phase 1NCT06684639

A Study on the Efficacy of GD2-CAR T Cells in the Treatment of Neuroblastoma

An Open Clinical Study on the Safety and Efficacy of Autologous GD2-CAR T Cells in the Treatment of Relapsed Refractory Neuroblastoma


Sponsor

The General Hospital of Western Theater Command

Enrollment

30 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Neuroblastoma (NB) is a malignant tumor of the sympathetic nervous system.Chemotherapy and autologous hematopoietic stem cell transplantation are the main treatments for neuroblastoma, and the prognosis of patients with high-risk recurrence and refractory treatment is very poor. There is a large unmet medical need in patients with relapsed refractory neuroblastoma, and further research into new therapeutic approaches is needed for these patients.GD2 is a dissialic ganglioside expressed by neuroectodermal tumors. The proportion of GD2 expression in neuroblastoma is up to 100%, so GD2 is a specific target for neuroblastoma immunotherapy and an ideal target for CAR-T treatment of neuroblastoma.


Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cell therapy called GD2-CAR T cells — where your own immune cells are reprogrammed to find and attack neuroblastoma cancer cells — in children with relapsed or treatment-resistant neuroblastoma. **You may be eligible if...** - Your child has been diagnosed with neuroblastoma that has come back or is not responding to treatment - The tumor cells test positive for a protein called GD2 - Your child is between 1 and 18 years old - Their heart, liver, lung, and kidney function are adequate - There is no active serious infection **You may NOT be eligible if...** - Your child has another active cancer - They have uncontrolled infection (bacterial, viral, or fungal) - They are HIV positive or have active hepatitis B or C - They have a serious heart condition or a history of brain seizures - They are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGD2-CAR-T cell

Split intravenous infusion of GD2-CAR-T cells \[dose escalating infusion of (1-100)x10\^6 GD2-CAR-T cells/kg\]


Locations(1)

The General Hospital of Western Theater Command

Chengdu, Sichuan, China

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NCT06684639


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