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

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ClinicalTrials.gov Identifier: NCT05608148
Recruitment Status : Recruiting
First Posted : November 8, 2022
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Kyushu University

Study Description
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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 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2
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 : 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
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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
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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
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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
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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
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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
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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: November 10, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroblastoma
Lung Neoplasms
Recurrence
Neoplasms
Neoplastic Processes
Pathologic Processes
Disease Attributes
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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases