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

Pediatric Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608148
• Other study ID #: GAIA-102-PT
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2022
• Est. completion date: August 25, 2027

Study information

• Verified date: March 2024
• Source: Kyushu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single 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 C(GAIA-102 with Nivolumab):Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 25, 2027
• Est. primary completion date: August 25, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 24 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Patients 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.

Related Conditions & MeSH terms

• Neuroblastoma
• Pediatric Solid Tumors
• Recurrence

Intervention

Biological:
• Biological
Intravenous injection of GAIA-102 alone
• Biological
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
• Biological
Intravenous injection of GAIA-102 with nivolumab combination

Locations

Country	Name	City	State
Japan	Kyushu University Hospital	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kyushu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate and Disease Control Rate		Cycle 1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days)
Secondary	Progression free Survival		2 year
Secondary	Overall Survival		2 year
Secondary	Frequency and severity of adverse events		2 year