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

Kyushu University

Status and phase: Enrolling; Phase 1

Conditions: Refractory/Relapse Neuroblastoma; Pediatric Solid Tumors

Treatments: Biological: Biological

Study type: Interventional

Funder types: Other

Identifiers

NCT05608148

GAIA-102-PT

Details and patient eligibility

About

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.

Enrollment: 61 estimated patients

Sex: All

Ages: 1 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 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.
   • 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

GAIA-102 alone

Experimental group

Description:

GAIA-102: 5 x 10\^6 cells / dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks

Treatment:

Biological: Biological

Biological: Biological

Biological: Biological

Biological: Biological

GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination

Experimental group

Description:

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

Treatment:

Biological: Biological

Biological: Biological

Biological: Biological

Biological: Biological

GAIA-102 with Nivolumab combination

Experimental group

Description:

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 Day1,15

Treatment:

Biological: Biological

Biological: Biological

Biological: Biological

Biological: Biological

GAIA-102 with Nivolumab, Teceleukin combination

Experimental group

Description:

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 Day8,22 Teceleukin: 750,000 units/m2/day on Day1-4 and 1,000,000 units/m2/day on Day 15-18

Treatment:

Biological: Biological

Biological: Biological

Biological: Biological

Biological: Biological