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

NCT05608148 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-11-18

No results posted yet for this 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.

Conditions

  • Refractory/Relapse Neuroblastoma
  • Pediatric Solid Tumors

Interventions

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

Sponsors & Collaborators

  • Kyushu University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-26
Primary Completion
2027-08-25
Completion
2027-08-25

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608148 on ClinicalTrials.gov