Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-11-07; most recent amendment 2025-11-14.
Trial Details
NCT Number NCT05608148
Lead Sponsor Kyushu University
Conditions Refractory/Relapse Neuroblastoma, Pediatric Solid Tumors
Enrollment 61 participants
Start Date 2022-10-26
Primary Completion 2027-08-25 (estimated)
Study Completion 2027-08-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-07