High Risk and/or relapsed/refractory Neuroblastoma and other relapsed/refractory GD2+ tumors
Conditions
Brief summary
Phase I primary end-points 1. To evaluate the safety of the infusion of iC9-GD2-CAR T cells at different escalating/de-escalating doses and establish the dose limiting toxicity (DLT) of the cellular product. Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0. DLT will be defined as any of the following that is not pre-existing, due to infection or to underlying malignancy and that may be considered possibly, probably or definite
Detailed description
Phase I and II secondary end-points 1. To assess the in vivo persistence and expansion of the infused T cells in the peripheral blood (PB), BM and in the Cerebro-Spinal Fluid (CSF) using immunoassays and transgene detection (Real Time qPCR), both for the whole population and the specific T cells subsets. 2. To evaluate the tumor infiltration of the infused T cells through Immunohistochemistry (IHC), flow cytometry and/or transgene detection (Real Time qPCR), whenever the tumor sample is availa
Interventions
DRUGCYCLOPHOSPHAMIDE
DRUGFLUDARABINE
Sponsors
Ospedale Pediatrico Bambino Gesu
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I primary end-points 1. To evaluate the safety of the infusion of iC9-GD2-CAR T cells at different escalating/de-escalating doses and establish the dose limiting toxicity (DLT) of the cellular product. Toxicity will be evaluated according to the Common Terminology Criteria for Adverse Event (CTC AE) scale, version 4.0. DLT will be defined as any of the following that is not pre-existing, due to infection or to underlying malignancy and that may be considered possibly, probably or definite | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I and II secondary end-points 1. To assess the in vivo persistence and expansion of the infused T cells in the peripheral blood (PB), BM and in the Cerebro-Spinal Fluid (CSF) using immunoassays and transgene detection (Real Time qPCR), both for the whole population and the specific T cells subsets. 2. To evaluate the tumor infiltration of the infused T cells through Immunohistochemistry (IHC), flow cytometry and/or transgene detection (Real Time qPCR), whenever the tumor sample is availa | — |
Countries
Italy
Outcome results
None listed