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

Sponsor
The General Hospital of Western Theater Command
Study ID
NCT06684639
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Nov 12, 2024
Start date
Dec 1, 2024
Status verified
Oct 2024
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    GD2 positive relapsed or refractory neuroblastoma

Primary Outcome Measure

Number of Adverse Events [ Time Frame: 24 months ]

Central Contacts

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