Clinical trial NCT05608148: Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Official title: Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Refractory/Relapse Neuroblastoma
Pediatric Solid Tumors
Lead sponsor: Kyushu University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Presence or absence of Dose Limiting Toxicity(DLT) expression
timeFrame: At the end of Cycle1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days)
Secondary outcomes:
measure: Objective Response Rate and Disease Control Rate
timeFrame: Cycle 1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days)
measure: Progression free Survival
timeFrame: 2 year
measure: Overall Survival
timeFrame: 2 year
measure: Frequency and severity of adverse events
timeFrame: 2 year
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
Study officials:
References: