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

November 14, 2025 updated by: Kyushu University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

61

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GAIA-102 alone
GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks
Biological: Biological
Intravenous injection of GAIA-102 alone
Biological: Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination
Experimental: GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination
GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks Filgrastim: 5 µg/kg/day on Day1-14 Teceleukin: 750,000 units/m2/day on Day29-31 and 1,000,000 units/m2/day on Day 36- 39 Dinutuximab: 17.5mg/m2/day on Day4-7 and Day36-39
Biological: Biological
Intravenous injection of GAIA-102 alone
Biological: Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination
Experimental: GAIA-102 with Nivolumab combination
GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 3 doses / week for 3 consecutive weeks Nivolumab: 3mg/kg/day(Children) or 240mg/day(Adults) on Day1,15
Biological: Biological
Intravenous injection of GAIA-102 alone
Biological: Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination
Experimental: GAIA-102 with Nivolumab, Teceleukin combination
GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 3 doses / week for 3 consecutive weeks Nivolumab: 3mg/kg/day(Children) or 240mg/day(Adults) on Day8,22 Teceleukin: 750,000 units/m2/day on Day1-4 and 1,000,000 units/m2/day on Day 15-18
Biological: Biological
Intravenous injection of GAIA-102 alone
Biological: Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab combination
Biological: Biological
Intravenous injection of GAIA-102 with nivolumab, teceleukin combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence or absence of Dose Limiting Toxicity(DLT) expression
Time Frame: At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)
At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)
Frequency and severerity of adverse events(Cohort C＆D)
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of adverse events
Time Frame: 2 year
2 year
Objective reponse rate and presence or absence of new lesions
Time Frame: 2 year
2 year
Overall survival rate and progression free survival rate
Time Frame: 2 year
2 year
Best overall response and lesion control rate
Time Frame: 2 year
2 year
Frequency and severerity of immune-related adverse events
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyushu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Estimated)

August 25, 2027

Study Completion (Estimated)

August 25, 2027

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAIA-102-PT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Solid Tumors

Clinical Trials on Biological

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe