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

NCT ID: NCT05608148

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2027-08-25

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.

Conditions

Refractory/Relapse Neuroblastoma; Pediatric Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GAIA-102 alone

GAIA-102: 5 x 10\^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks

Group Type: EXPERIMENTAL

Biological

Intervention Type: BIOLOGICAL

Intravenous injection of GAIA-102 alone

GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination

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

Group Type: EXPERIMENTAL

Biological

Intervention Type: BIOLOGICAL

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

GAIA-102 with Nivolumab combination

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

Group Type: EXPERIMENTAL

Biological

Intervention Type: BIOLOGICAL

Intravenous injection of GAIA-102 with nivolumab combination

GAIA-102 with Nivolumab, Teceleukin combination

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

Group Type: EXPERIMENTAL

Biological

Intervention Type: BIOLOGICAL

Intravenous injection of GAIA-102 with nivolumab, teceleukin combination

Interventions

Biological

Intravenous injection of GAIA-102 alone

Intervention Type: BIOLOGICAL

Biological

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

Intervention Type: BIOLOGICAL

Biological

Intravenous injection of GAIA-102 with nivolumab combination

Intervention Type: BIOLOGICAL

Biological

Intravenous injection of GAIA-102 with nivolumab, teceleukin combination

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.

4. Patients aged from 1years to 24 years at the time of obtaining consent.

5. 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

1. Patients with brain metastases.

2. Patients diagnosed with cancerous meningitis

3. Patients who received allogeneic hematopoietic stem cell transplant.

4. Patients with active autoimmune disease.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyushu University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Site Status: RECRUITING

Countries

Japan

Facility Contacts

Naonori Kawakubo

Role: primary

kawakubo.naonori.061@m.kyushu-u.ac.jp

+81-92-642-5573

Other Identifiers

GAIA-102-PT

Identifier Type: -

Identifier Source: org_study_id