AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 1Ages 1 Year - 24 YearsAllKyushu University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. 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. 3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs. 4. Patients aged from 1years to 24 years at the time of obtaining consent. 5. 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 Criteria: 1. Patients with brain metastases. 2. Patients diagnosed with cancerous meningitis 3. Patients who received allogeneic hematopoietic stem cell transplant. 4. Patients with active autoimmune disease.
๐Ÿ’Š

What it tests

  • Biological
  • Biological
  • Biological
  • Biological
๐Ÿ“

Where

1 site
Kyushu University Hospital
Fukuoka, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy