drugset / Trial / NCT05608148
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Cohort A(GAIA-102 alone): Confirm the safety of GAIA-102 alone for refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II. Cohort B(GAIA-102 with Dinutuximab): Confirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory/relapse neuroblastoma and decide recommended dose for Phase II. Cohort C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab. Cohort D(GAIA-102 with Nivolumab, Teceleukin): Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab, Teceleukin.
Timeline
- Start
- 2022-10-26
- Primary completion
- 2027-08-25
- Completion
- 2027-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GAIA-102 | Cell therapy | 5e+06 cells | Intravenous |
| Background | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | — |
| Background | Nivolumab | Monoclonal antibody | 3 mg/kg | — |
| Background | Nivolumab | Monoclonal antibody | 240 mg | — |
| Background | Teceleukin | Protein / enzyme biologic | 1e+06 unknown | — |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | — |