Clinical Trial of GAIA-102 for Refractory/Relapse Neuroblastomas and Other Malignant Pediatric Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Presence or absence of Dose Limiting Toxicity(DLT) expression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •Patients with brain metastases.
- •Patients diagnosed with cancerous meningitis
- •Patients who received allogeneic hematopoietic stem cell transplant.
- •Patients with active autoimmune disease.
研究组 & 干预措施
GAIA-102 with Dinutuximab, Filgrastim, Teceleukin combination
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
干预措施: Biological (Biological)
GAIA-102 with Nivolumab combination
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
干预措施: Biological (Biological)
GAIA-102 with Nivolumab, Teceleukin combination
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
干预措施: Biological (Biological)
GAIA-102 alone
GAIA-102: 5 x 10^6 cells /㎏/ dose at a fixed dose, 1 to 3 doses / week for 3 consecutive weeks
干预措施: Biological (Biological)
结局指标
主要结局
Presence or absence of Dose Limiting Toxicity(DLT) expression
时间窗: At the end of Cycle1 (Cohort A & C & D: Cycle period is 28 days, Cohort B: Cycle period is 56 days)
Frequency and severerity of adverse events(Cohort C＆D)
时间窗: 2 year
次要结局
- Frequency and severity of adverse events(2 year)
- Objective reponse rate and presence or absence of new lesions(2 year)
- Overall survival rate and progression free survival rate(2 year)
- Best overall response and lesion control rate(2 year)
- Frequency and severity of adverse events(2 year)
- Frequency and severerity of immune-related adverse events(2 year)