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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAIA-102 alone | Experimental | GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks |
|
| GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination | Experimental | 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 |
|
| GAIA-102 with Nivolumab combination | Experimental | GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 3 doses / week for 3 consecutive weeks Nivolumab: 3mg/kg/day(Children) or 240mg/day(Adults) on Day1,15 |
|
| GAIA-102 with Nivolumab, Teceleukin combination | Experimental | GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 3 doses / week for 3 consecutive weeks Nivolumab: 3mg/kg/day(Children) or 240mg/day(Adults) on Day8,22 Teceleukin: 750,000 units/m2/day on Day1-4 and 1,000,000 units/m2/day on Day 15-18 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological | Biological | Intravenous injection of GAIA-102 alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Presence or absence of Dose Limiting Toxicity(DLT) expression | At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days) | |
| Frequency and severerity of adverse events(Cohort C&D) | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective reponse rate and presence or absence of new lesions | 2 year | |
| Overall survival rate and progression free survival rate | 2 year | |
| Best overall response and lesion control rate |
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Inclusion Criteria:
Patients who have been confirmed to have the following malignant tumor by histological examination
Undergoing the following treatment.
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu University Hospital | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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| 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 |
|
| 2 year |
| Frequency and severity of adverse events | 2 year |
| Frequency and severerity of immune-related adverse events | 2 year |