NCT05608148

Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Kyushu University · Academic / Other
• Sex: All
• Age: 1 Year – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory/Relapse Neuroblastoma
• Pediatric Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Biological	Intravenous injection of GAIA-102 alone
BIOLOGICAL	Biological	Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
BIOLOGICAL	Biological	Intravenous injection of GAIA-102 with nivolumab combination
BIOLOGICAL	Biological	Intravenous injection of GAIA-102 with nivolumab, teceleukin combination

Timeline

• Start date: 2022-10-26
• Primary completion: 2027-08-25
• Completion: 2027-08-25
• First posted: 2022-11-08
• Last updated: 2025-11-18

Locations

1 site across 1 country: Japan