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Phase I Study of Donor Derived,Gene Modified, Multi-virus-specific, Cytotoxic T-Lymphocytes Redirected to GD2 for Relapsed/Refractory Neuroblastoma Post-allo Stem Cell Transplantation With Submyeloblative Conditioning (STALLONe)
This is a single-center, investigator-initiated, single-arm, pilot study of post-allogeneic transplant, adoptive immunotherapy for the treatment of patients with relapsed/refractory neuroblastoma expressing the mesenchymal tumor marker GD2. Three patients will be treated. The study will focus on the safety and efficacy of allogeneic, donor derived viral specific cytotoxic T-lymphocytes, retrovirally transduced to express a chimeric antigen receptor specific for disialoganglioside, GD2, expressed on neuroblastoma.
Details
| Lead sponsor | Children's Mercy Hospital Kansas City |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 5 |
| Start date | 2012-10 |
| Completion | 2015-01 |
Conditions
- Neuroblastoma
Interventions
- GD2 CAR modified Tri-virus specific cytotoxic t-cells
Primary outcomes
- Number of Participants With Immediate and Short Term Toxicity of Infusion Over 8 Weeks — Post infusion week 8
Immediate: Patients were monitored following infusion to assess for toxicity related to infusion. Potential toxicities related to cellular therapy infusions, such as allergic reaction to the cellular product or cryopreservation media, hemolytic reactions, volume overload, and hemodynamic instability, were monitored. Short Term: Patients were monitored for 8 weeks for short term toxicity related to infusion. Such adverse reactions monitored were acute graft versus host disease and cytokine release syndrome. - Peak Transgene Copy Number Per 1000ng PBMC DNA — 1 year
Peak Transgene Copy Number per 1000ng PBMC DNA from peripheral blood samples measured during study participation. - Death Within 8 Weeks of Infusion — 8 weeks
Countries
United States