Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-24
SponsorKyushu University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients with brain metastases.
Patients diagnosed with cancerous meningitis
Patients who received allogeneic hematopoietic stem cell transplant.
Patients with active autoimmune disease.
Trial design
Treatments tested in this trial
- Biological
- Biological
- Biological
- Biological
Treatment groups
61 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov