Study on GD2 Positive Solid Tumors by 4SCAR-GD2

Sponsor
Shenzhen Geno-Immune Medical Institute
Study ID
NCT02992210
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 4SCAR-GD2 — GENETIC
    GD2-specific 4th Generation CART

Study Details

Patients with refractory and/or recurrent solid tumor have poor prognosis despite complex multimodel therapy and therefore, novel approaches are urgently needed. The investigators are attempt to treat these diseases using T cells genetically modified with a 4th generation lentiviral chimeric antigen receptor (4SCAR fused with an inducible apoptotic caspase 9 domain) targeting GD2 (4SCAR-GD2). The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognition of GD2, a surface protein expressed at high levels on many types of tumors but not on normal tissues. This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and/or recurrent tumors.

Key Dates

First listed
Dec 14, 2016
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: effectiveness of 4SCAR-GD2 T cells
    The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognize of GD2 .This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and recurrent solid tumors

Primary Outcome Measure

Number of patients with adverse events. [ Time Frame: 3 year ]

Central Contacts

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