At a glance
ClinicalIndex Comparison Record- ✓GD2-positive solid tumor confirmed by immunohistochemistry or flow cytometry
- ✓Received standard first-line therapy with non-resectable, metastatic, progressive or recurrent disease
- ✓Age 1 to 65 years at enrollment
- ✓Body weight ≥10 kg
- ✕Severe cardiac, pulmonary, hepatic diseases or major organ dysfunction (except grade 3 hematologic toxicity)
- ✕Untreated CNS metastases
- ✕Prior treatment with genetically engineered GD2-CAR T cells
- ✕Active HIV, HBV, HCV infection or uncontrolled infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter Trial of Phase I/II Studies on GD2 Positive Solid Tumors by 4SCAR-GD2
In Brief
A Phase 2 clinical trial evaluating 4SCAR-GD2 for Solid Tumor. Currently recruiting, targeting 100 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
GD2-specific 4th Generation CART