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Refractory/Relapse NeuroblastomaPhase 1NCT05608148

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

A Phase 1 study testing Biological in people with Refractory/Relapse Neuroblastoma and Pediatric Solid Tumors, run by Kyushu University at 1 site in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 1 year to 24 years
What is being tested?
Biological
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteJapan
Study dates
26 Oct 2022to 25 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients who have been confirmed to have the following malignant tumor by histological examination
  • cohort A : 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) .
  • cohort B : neuroblastoma.
  • cohort C \& D : neuroblastoma and other malignant solid tumors, rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma.
  • Undergoing the following treatment.
  • cohort A \& B : Patients who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
Show all 10Show fewer
  • cohort C \& D : Patients with neuroblastoma who have completed the dinutuximab regimen and still have residual tumor. Patients with rhabdomyosarcoma, Ewing's sarcoma family, hepatoblastoma who have the resistance for more than two treatment regimens, and the resistance for all standard regimens based on the guideline.
  • Patients who have medical history for serious side effect , allergy reaction with regards to concomitant drugs.
  • Patients aged from 1years to 24 years at the time of obtaining consent.
  • 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.

Who cannot join

  • Patients with brain metastases.
  • Patients diagnosed with cancerous meningitis
  • Patients who received allogeneic hematopoietic stem cell transplant.
  • Patients with active autoimmune disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Japan1 site, 1 recruiting

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

    Naonori Kawakubo, +81-92-642-5573, kawakubo.naonori.061@m.kyushu-u.ac.jp

    Recruiting

Other trials in Japan

About this study

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 D(GAIA-102 with Nivolumab, Teceleukin):

Confirm the safety of GAIA-102(Follow the recommended doses in Cohort A) with Nivolumab, Teceleukin.

Being tested
Biological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiologicalBiological

    Intravenous injection of GAIA-102 alone

  • BiologicalBiological

    Intravenous injection of GAIA-102 with dinutuximab, filgrastim, teceleukin combination

  • BiologicalBiological

    Intravenous injection of GAIA-102 with nivolumab combination

  • BiologicalBiological

    Intravenous injection of GAIA-102 with nivolumab, teceleukin combination

Study groups in NCT05608148
Study groupRoleWhat they receive
GAIA-102 aloneExperimentalGAIA-102: 5 x 10^6 cells /㎏/ dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks
Receives: Biological: Biological
GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combinationExperimentalGAIA-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
Receives: Biological: Biological
GAIA-102 with Nivolumab combinationExperimentalGAIA-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 Day1,15
Receives: Biological: Biological
GAIA-102 with Nivolumab, Teceleukin combinationExperimentalGAIA-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 Day8,22 Teceleukin: 750,000 units/m2/day on Day1-4 and 1,000,000 units/m2/day on Day 15-18
Receives: Biological: Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence or absence of Dose Limiting Toxicity(DLT) expression

    Measured: At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)

  2. Frequency and severerity of adverse events(Cohort C＆D)

    Measured: 2 year

Secondary outcomes (5)

  1. Objective reponse rate and presence or absence of new lesions

    Measured: 2 year

  2. Overall survival rate and progression free survival rate

    Measured: 2 year

  3. Best overall response and lesion control rate

    Measured: 2 year

  4. Frequency and severity of adverse events

    Measured: 2 year

  5. Frequency and severerity of immune-related adverse events

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start26 Oct 2022
  3. Primary completion25 Aug 2027 (estimated)
  4. Study completion25 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
61 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05608148
Sponsor's protocol ID
GAIA-102-PT
Status last verified
Aug 2026
First submitted
24 Oct 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biological in people with Refractory/Relapse Neuroblastoma and Pediatric Solid Tumors, run by Kyushu University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence or absence of Dose Limiting Toxicity(DLT) expression (time frame: At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05608148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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