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RECRUITING
NCT05608148
PHASE1

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

Sponsor: Kyushu University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Year - 24 Years

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2022-10-26

Completion Date

2027-08-25

Last Updated

2025-11-18

Healthy Volunteers

No

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

Locations (1)

Kyushu University Hospital

Fukuoka, Fukuoka, Japan