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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Intravenous injection of GAIA-102 alone
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Intravenous injection of GAIA-102 with nivolumab combination
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGPresence or absence of Dose Limiting Toxicity(DLT) expression
Time frame: At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)
Frequency and severerity of adverse events(Cohort C&D)
Time frame: 2 year
Objective reponse rate and presence or absence of new lesions
Time frame: 2 year
Overall survival rate and progression free survival rate
Time frame: 2 year
Best overall response and lesion control rate
Time frame: 2 year
Frequency and severity of adverse events
Time frame: 2 year
Frequency and severerity of immune-related adverse events
Time frame: 2 year
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