Tests GAIA-102 safety in children with relapsed neuroblastoma and solid tumors
Tests GAIA-102, alone or with other drugs, in children with neuroblastoma or solid tumors.
Plain-language title generated from the registry record
Registry title: Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Key facts
- Where
- Fukuoka, JapanSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 24 years old?
Source: NCT05608148, who can take part
Where in Japan
- Kyushu University HospitalFukuoka, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kyushu University
- Trial code
- NCT05608148
- Record updated
- 7 August 2026
- Original description
Cohort A(GAIA-102 alone):Read full original descriptionShow less
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
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.
Inclusion: Patients who have been confirmed to have the following malignant tumor by histological examination; cohort A : neuroblastoma or malignant solid tumor with pulmonary metastases, rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family, osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germ cell neoplasma, other rare solid tumor (except brain tumor and brain metastases) ; cohort B : neuroblastoma; cohort C \& D : neuroblastoma and other malignant solid tumors, rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma; Undergoing the following treatment; cohort A \& B : Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline; cohort C \& D : Patients with neuroblastoma who have completed the dinutuximab regimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline; Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs; Patients aged from 1years to 24 years at the time of obtaining consent; Patients with performance status(PS) over 50 (Lansky Performance Status Score less than 16 years old) or (Karnofsky Performance Status over 16 years old) at the time of obtaining consent.
Exclusion: Patients who received allogeneic hematopoietic stem cell transplant; Patients with active autoimmune disease; Patients with brain metastases; Patients diagnosed with cancerous meningitis.