The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05608148
Recruitment Status : Recruiting
First Posted : November 8, 2022
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Kyushu University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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


Condition or disease Intervention/treatment Phase
Refractory/Relapse Neuroblastoma Pediatric Solid Tumors Biological: Biological Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Actual Study Start Date : October 26, 2022
Estimated Primary Completion Date : August 25, 2027
Estimated Study Completion Date : August 25, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Experimental: 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
 Biological: Biological
Intravenous injection of GAIA-102 with nivolumab combination


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Presence or absence of Dose Limiting Toxicity(DLT) expression [ Time Frame: At the end of Cycle1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days) ]

Secondary Outcome Measures :
  1. Objective Response Rate and Disease Control Rate [ Time Frame: Cycle 1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days) ]
  2. Progression free Survival [ Time Frame: 2 year ]
  3. Overall Survival [ Time Frame: 2 year ]
  4. Frequency and severity of adverse events [ Time Frame: 2 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05608148


Locations
Layout table for location information
Japan
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Naonori Kawakubo    +81-92-642-5573    kawakubo.naonori.061@m.kyushu-u.ac.jp   
Sponsors and Collaborators
Kyushu University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Kyushu University
ClinicalTrials.gov Identifier: NCT05608148    
Other Study ID Numbers: GAIA-102-PT
First Posted: November 8, 2022    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroblastoma
Recurrence
Neoplasms
Disease Attributes
Pathologic Processes
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
 Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue