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

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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

Tracking Information
First Submitted Date  ICMJE October 24, 2022
First Posted Date  ICMJE November 8, 2022
Last Update Posted Date March 28, 2024
Actual Study Start Date  ICMJE October 26, 2022
Estimated Primary Completion Date August 25, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2022)		 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2022)		 Presence or absense of DLT expression [ Time Frame: At the end of Cycle1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2022)
  • 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) ]
  • Progression free Survival [ Time Frame: 2 year ]
  • Overall Survival [ Time Frame: 2 year ]
  • Frequency and severity of adverse events [ Time Frame: 2 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2022)
  • Objective Reponse Rate and Disease Control Rate [ Time Frame: Cycle 1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days) ]
  • Progression free Survival [ Time Frame: 2 year ]
  • Overall Survival [ Time Frame: 2 year ]
  • Frequency and severerity of adverse events [ Time Frame: 2 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Official Title  ICMJE Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory/Relapse Neuroblastoma
  • Pediatric Solid Tumors
Intervention  ICMJE
  • Biological: Biological
    Intravenous injection of GAIA-102 alone
  • Biological: Biological
    Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
  • Biological: Biological
    Intravenous injection of GAIA-102 with nivolumab combination
Study Arms  ICMJE
  • 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
    Intervention: Biological: Biological
  • 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
    Intervention: Biological: Biological
  • 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
    Intervention: Biological: Biological
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2024)		 56
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2022)		 36
Estimated Study Completion Date  ICMJE August 25, 2027
Estimated Primary Completion Date August 25, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05608148
Other Study ID Numbers  ICMJE GAIA-102-PT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kyushu University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kyushu University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kyushu University
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP