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

Last updated: March 26, 2024
Sponsor: Kyushu University
Overall Status: Active - Recruiting

Phase

1

Condition

Neuroblastoma

Neoplasm Metastasis

Treatment

Biological

Clinical Study ID

NCT05608148
GAIA-102-PT
  • Ages 1-24
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who have been confirmed to have the following malignant tumor by histologicalexamination
  • 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.
  1. Patients who have the resistance for more than two treatment regimens, and theresistance for all standard regimens based on the guideline.
  2. Patients who have medical history for serious side effect , allergy reaction withregards to concomitant drugs.
  3. Patients aged from 1years to 24 years at the time of obtaining consent.
  4. Patients with performance status(PS) over 50 (Lansky Performance Status Score lessthan 16 years old) or (Karnofsky Performance Status over 16 years old) at the time ofobtaining consent.

Exclusion

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.

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: Biological
Phase: 1
Study Start date:
October 26, 2022
Estimated Completion Date:
August 25, 2027

Connect with a study center

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

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