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

Inclusion Criteria10

  • 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.
  • 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.
  • Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.
  • Patients aged from 1years to 24 years at the time of obtaining consent.
  • 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 Criteria4

  • Patients with brain metastases.
  • Patients diagnosed with cancerous meningitis
  • Patients who received allogeneic hematopoietic stem cell transplant.
  • Patients with active autoimmune disease.

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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