Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
1 other identifier
interventional
61
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2022
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 25, 2027
November 18, 2025
November 1, 2025
4.8 years
October 24, 2022
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (5)
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
2 year
Frequency and severity of adverse events
2 year
Frequency and severerity of immune-related adverse events
2 year
Study Arms (4)
GAIA-102 alone
EXPERIMENTALGAIA-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
EXPERIMENTALGAIA-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
EXPERIMENTALGAIA-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
EXPERIMENTALGAIA-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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with brain metastases.
- Patients diagnosed with cancerous meningitis
- Patients who received allogeneic hematopoietic stem cell transplant.
- Patients with active autoimmune disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
November 8, 2022
Study Start
October 26, 2022
Primary Completion (Estimated)
August 25, 2027
Study Completion (Estimated)
August 25, 2027
Last Updated
November 18, 2025
Record last verified: 2025-11