RecruitingPhase 1NCT05608148

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


Sponsor

Kyushu University

Enrollment

61 participants

Start Date

Oct 26, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment called GAIA-102 for children and young people with hard-to-treat solid tumors including neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma, liver cancer (hepatoblastoma), kidney cancer (nephroblastoma), and others. **You may be eligible if...** - You have been diagnosed with one of the listed pediatric malignant solid tumors (confirmed by biopsy) - Your cancer has relapsed or not responded to prior treatment - You are enrolled in one of the specific cohorts matching your tumor type **You may NOT be eligible if...** - You have a brain tumor or brain metastases (except certain cohorts) - Your overall health status does not meet the study's requirements - You have not been histologically confirmed (check with your doctor for all eligibility details) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBiological

Intravenous injection of GAIA-102 alone

BIOLOGICALBiological

Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination

BIOLOGICALBiological

Intravenous injection of GAIA-102 with nivolumab combination

BIOLOGICALBiological

Intravenous injection of GAIA-102 with nivolumab, teceleukin combination


Locations(1)

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

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NCT05608148


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