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Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Sponsor: Kyushu University
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.
Key Details
Gender
All
Age Range
1 Year - 24 Years
Study Type
INTERVENTIONAL
Enrollment
61
Start Date
2022-10-26
Completion Date
2027-08-25
Last Updated
2025-11-18
Healthy Volunteers
No
Interventions
Biological
Intravenous injection of GAIA-102 alone
Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Biological
Intravenous injection of GAIA-102 with nivolumab combination
Biological
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination
Locations (1)
Kyushu University Hospital
Fukuoka, Fukuoka, Japan