Actively Recruiting
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Led by Kyushu University · Updated on 2025-11-18
61
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients confirmed by tissue exam to have neuroblastoma or certain malignant solid tumors with lung metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasm, or other rare solid tumors except brain tumors and brain metastases
- Patients aged 1 to 24 years at the time of consent
- Patients with performance status over 50 (Lansky for under 16 years old, Karnofsky for 16 years or older) at consent
- Cohort A & B: Patients resistant to more than two treatment regimens and all standard guideline regimens
- Cohort B: Patients with neuroblastoma
- Cohort C & D: Patients with neuroblastoma who completed dinutuximab and have residual tumor or patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma resistant to more than two treatment regimens and all standard regimens
- Patients with medical history of serious side effects or allergic reactions to related drugs
You will not qualify if you...
- Patients with brain metastases
- Patients diagnosed with cancerous meningitis
- Patients who received allogeneic hematopoietic stem cell transplant
- Patients with active autoimmune disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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