Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas or Malignant Pediatric Solid Tumors With Lung Metastases

Study Overview
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Brief Summary
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Single Cohort: Confirm the safety of GAIA-102 alone refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II. Combination Cohort: Confirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory/relapse neuroblastoma and decide recommended dose for Phase II.

Official Title
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Phase I Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas or Malignant Pediatric Solid Tumors With Lung Metastases

Conditions
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Refractory/Relapse Neuroblastoma, Pediatric Solid Tumors With Lung Metastases

Intervention / Treatment
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* Biological: Biological
* Biological: Biological


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been confirmed to have the following malignant tumor by histological examination single cohort : 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) . combination cohort : neuroblastoma. Patients 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 Criteria: Patients with brain metastases. Patients diagnosed with cancerous meningitis Patients who received allogeneic hematopoietic stem cell transplant. Patients with active autoimmune disease.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAIA-102 alone<br>GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks. | Biological: Biological<br>* Intravenous injection of GAIA-102 alone<br>|
| Experimental: GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination<br>GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks. Filgrastim: 5 µg/kg/day on Day1-14 Teceleukin: 750,000 units/m2/day on Day29-31 and 1,000,000 units/m2/day on Day 36- 39 Dinutuximab: 17.5mg/m2/day on Day4-7 and Day36-39 | Biological: Biological<br>* Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of Dose Limiting Toxicity(DLT) expression |  | At the end of Cycle1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate and Disease Control Rate |  | Cycle 1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days) | 
| Progression free Survival |  | 2 year | 
| Overall Survival |  | 2 year | 
| Frequency and severity of adverse events |  | 2 year |