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

ConditionsRefractory/Relapse NeuroblastomaPediatric Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-24
SponsorKyushu University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with brain metastases.

Patients diagnosed with cancerous meningitis

Patients who received allogeneic hematopoietic stem cell transplant.

Patients with active autoimmune disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biological

    Biological/Vaccine

    Intravenous injection of GAIA-102 alone

  • Biological

    Biological/Vaccine

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

  • Biological

    Biological/Vaccine

    Intravenous injection of GAIA-102 with nivolumab combination

  • Biological

    Biological/Vaccine

    Intravenous injection of GAIA-102 with nivolumab, teceleukin combination

Treatment groups

61 Participants
are divided into 4 treatment groups
Group A: GAIA-102 aloneExperimental treatment 1 intervention
Group B: GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combinationExperimental treatment 1 intervention
Group C: GAIA-102 with Nivolumab combinationExperimental treatment 1 intervention
Group D: GAIA-102 with Nivolumab, Teceleukin combinationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

Frequency and severerity of adverse events(Cohort C＆D)

Time frame
2 year

Secondary outcomes

1

Objective reponse rate and presence or absence of new lesions

Time frame
2 year
2

Overall survival rate and progression free survival rate

Time frame
2 year
3

Best overall response and lesion control rate

Time frame
2 year
4

Frequency and severity of adverse events

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyushu University

Lead sponsor

Source ClinicalTrials.gov
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