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

Last updated: November 14, 2025
Sponsor: Kyushu University
Overall Status: Active - Recruiting

Phase

1

Condition

Neuroblastoma

Neoplasm Metastasis

Treatment

Biological

Clinical Study ID

NCT05608148
GAIA-102-PT
  • Ages 1-24
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  1. Patients who have been confirmed to have the following malignant tumor byhistological examination
  • cohort A : neuroblastoma or malignant solid tumor with pulmonary metastases,rhabdomyosarcoma, undifferentiated sarcoma, Ewing's sarcoma family,osteosarcoma, other cartilage sarcoma, nephroblastoma, hepatoblastoma, germcell neoplasma, other rare solid tumor (except brain tumor and brainmetastases) .

  • cohort B : neuroblastoma.

  • cohort C & D : neuroblastoma and other malignant solid tumors,rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma.

  1. Undergoing the following treatment.
  • cohort A & B : Patients who have the resistance for more than two treatmentregimens, and the resistance for all standard regimens based on the guideline.

  • cohort C & D : Patients with neuroblastoma who have completed the dinutuximabregimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing'ssarcoma family, hepatoblastoma who have the resistance for more than twotreatment regimens, and the resistance for all standard regimens based on theguideline.

  1. Patients who have medical history for serious side effect , allergy reaction withregards to concomitant drugs.

  2. Patients aged from 1years to 24 years at the time of obtaining consent.

  3. Patients with performance status(PS) over 50 (Lansky Performance Status Score lessthan 16 years old) or (Karnofsky Performance Status over 16 years old) at the timeof obtaining consent.

Exclusion

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.

Study Design

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: Biological
Phase: 1
Study Start date:
October 26, 2022
Estimated Completion Date:
August 25, 2027

Connect with a study center

  • Kyushu University Hospital

    Fukuoka 1863967, Fukuoka 1863958 812-8582
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

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