Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas or Malignant Pediatric Solid Tumors With Lung Metastases

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Biological

About this trial

This is an interventional treatment trial for Refractory/Relapse Neuroblastoma

Eligibility Criteria

1 Year - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Patients 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. Exclusion Criteria: Patients with brain metastases. Patients diagnosed with cancerous meningitis Patients who received allogeneic hematopoietic stem cell transplant. Patients with active autoimmune disease.

Sites / Locations

Kyushu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

GAIA-102 alone

GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination

Arm Description

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

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

Outcomes

Primary Outcome Measures

Presence or absence of Dose Limiting Toxicity(DLT) expression

Secondary Outcome Measures

Objective Response Rate and Disease Control Rate

Progression free Survival

Overall Survival

Frequency and severity of adverse events

Full Information

NCT ID

NCT05608148

First Posted

October 24, 2022

Last Updated

November 7, 2022

Sponsor

Kyushu University

1. Study Identification

Unique Protocol Identification Number

NCT05608148

Brief Title

Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas or Malignant Pediatric Solid Tumors With Lung Metastases

Official Title

Phase I Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas or Malignant Pediatric Solid Tumors With Lung Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2022 (Actual)

Primary Completion Date

August 25, 2027 (Anticipated)

Study Completion Date

August 25, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyushu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Single Cohort: Confirm the safety of GAIA-102 alone refractory/relapse neuroblastoma or pediatric solid tumors with lung metastases, and decide recommended dose for Phase II. Combination Cohort: Confirm the safety of GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination for refractory/relapse neuroblastoma and decide recommended dose for Phase II.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory/Relapse Neuroblastoma, Pediatric Solid Tumors With Lung Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

2

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GAIA-102 alone

Arm Type

Experimental

Arm Description

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

Arm Title

GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination

Arm Type

Experimental

Arm 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

Intervention Type

Biological

Intervention Name(s)

Biological

Intervention Description

Intravenous injection of GAIA-102 alone

Intervention Type

Biological

Intervention Name(s)

Biological

Intervention Description

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

Primary Outcome Measure Information:

Title

Presence or absence of Dose Limiting Toxicity(DLT) expression

Time Frame

At the end of Cycle1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days)

Secondary Outcome Measure Information:

Title

Objective Response Rate and Disease Control Rate

Time Frame

Cycle 1 (Single Cohort: Cycle period is 28 days, Combination Cohort: Cycle period is 56 days)

Title

Progression free Survival

Time Frame

2 year

Title

Overall Survival

Time Frame

2 year

Title

Frequency and severity of adverse events

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Patients 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. Exclusion Criteria: Patients with brain metastases. Patients diagnosed with cancerous meningitis Patients who received allogeneic hematopoietic stem cell transplant. Patients with active autoimmune disease.

Facility Information:

Facility Name

Kyushu University Hospital

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Naonori Kawakubo

Phone

+81-92-642-5573

Email

kawakubo.naonori.061@m.kyushu-u.ac.jp

Refractory/Relapse Neuroblastoma, Pediatric Solid Tumors With Lung Metastases

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial