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Trial Title:
Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
NCT ID:
NCT05608148
Condition:
Refractory/Relapse Neuroblastoma
Pediatric Solid Tumors
Conditions: Official terms:
Neuroblastoma
Recurrence
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Biological
Description:
Intravenous injection of GAIA-102 alone
Arm group label:
GAIA-102 alone
Intervention type:
Biological
Intervention name:
Biological
Description:
Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination
Arm group label:
GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination
Intervention type:
Biological
Intervention name:
Biological
Description:
Intravenous injection of GAIA-102 with nivolumab combination
Arm group label:
GAIA-102 with Nivolumab combination
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
Criteria for eligibility:
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.
Gender:
All
Minimum age:
1 Year
Maximum age:
24 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Naonori Kawakubo
Phone:
+81-92-642-5573
Email:
kawakubo.naonori.061@m.kyushu-u.ac.jp
Start date:
October 26, 2022
Completion date:
August 25, 2027
Lead sponsor:
Agency:
Kyushu University
Agency class:
Other
Source:
Kyushu University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05608148
