Testing GAIA-102 for difficult-to-treat pediatric cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and recommended dosing of GAIA-102 in children with refractory or relapsed neuroblastoma and other malignant solid tumors. It consists of three cohorts: one testing GAIA-102 alone, another combining it with Dinutuximab, and a third with Nivolumab. The study aims to determine the safety of these combinations and establish appropriate doses for future phases. The trial focuses on patients who have not responded to standard treatments and have specific types of tumors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kyushu University Hospital
  Fukuoka, Fukuoka, Japan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.