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

Sponsor

Kyushu University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05608148

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory/Relapse Neuroblastoma Pediatric Solid Tumors With Lung Metastases	Biological: Biological Biological: Biological	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 26, 2022

Anticipated Primary Completion Date :

Aug 25, 2027

Anticipated Study Completion Date :

Aug 25, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GAIA-102 alone GAIA-102: 5 x 10^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks.	Biological: Biological Intravenous injection of GAIA-102 alone
Experimental: 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	Biological: Biological Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination

Arm

Intervention/Treatment

Experimental: GAIA-102 alone

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

Biological: Biological

Intravenous injection of GAIA-102 alone

Experimental: 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

Biological: Biological

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyushu University Hospital	Fukuoka		Japan	812-8582

Sponsors and Collaborators

Kyushu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kyushu University

ClinicalTrials.gov Identifier:

NCT05608148

Other Study ID Numbers:

GAIA-102-PT

First Posted:

Nov 8, 2022

Last Update Posted:

Nov 10, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2022