jRCT2031240693招募中不适用
A Phase 1 Study to Confirm the Tolerability of NPC-33 and NPC-26sc in High-Risk Neuroblastoma with Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow (NPC-33-1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 12month old over 至 No limit（—）
入选标准
- •Patients who meet all of the following inclusion criteria:
- •(1) Diagnosed with neuroblastoma (at least one of the following)
- •a. Histologically diagnosed with neuroblastoma by biopsy
- •b. Neuroblastoma is shown histologically by bone marrow aspiration or bone marrow biopsy. In addition, blood or urine catecholamine metabolite levels are high, or MYCN gene amplification is found.
- •c. Lesion shown by MIBG accumulation
- •(2) High-risk neuroblastoma with bone and/or bone marrow involvement that is new-onset and refractory or that responds inadequately to salvage therapy (SD, MR, or PR to previous treatment). If the lesion is limited to bone marrow, it must cover at least 5% of bone marrow.
- •a. For new-onset refractory cases, study enrollment (first dose of NPC-26sc) must be done within 18 months since initiation of chemotherapy, and subjects must have received at least 4 cycles of standard remission induction chemotherapy for high-risk neuroblastoma.
- •b. Inadequate response to salvage therapy must be limited to bone and/or bone marrow, and at least 2 months must have elapsed between the last MIBG/PET-CT confirmation of relapse or PD and study enrollment (first dose of NPC-26sc).
- •Patients with residual lesions localized to the primary retroperitoneal site after surgery and have undergone radiation therapy may be included. For new-onset refractory cases, the time required from completion of radiation therapy to enrollment in the study is at least 28 days.
- •(3) Life expectancy of at least 6 months at the time of informed consent
- •(4) Age of at least 12 months at the time of informed consent
- •(5) Hematological testing at time of screening meets the following criteria:
- •a. Hemoglobin => 8.0 g/dL
- •b. White blood cell count => 1000/micro L
- •c. Neutrophil count => 500/micro L
- •d. Platelet count => 25000/micro L
- •(6) Liver function values at time of screening meet the following criteria:
- •a. ALT and AST <= 5 times the upper limit of normal of the study site
- •[Patients under 15 years old should have values within five times the upper limit of the pediatric clinical reference range.]
- •b. Serum total bilirubin <= 1.5 times the upper limit of normal of the study site
- •(7) eGFR at time of screening => 60 mL/min/1.73 m2
- •(8) Written consent has been obtained from the legal representative and/or subject in person to participate in this study. For children, an assent form must be provided.
排除标准
- •Patients meeting any of the following exclusion criteria:
- •(1) Has received or is planned to receive systemic treatment (including chemotherapy or immunotherapy) for cancer within 3 weeks of the first dose of NPC-26
- •(2) Has MIBG- or FDG-PET-positive lesions other than bone and/or bone marrow
- •(However, patients who have limited retroperitoneal primary tumor after surgery and radiation therapy and have not experienced any subsequent exacerbation may be included even if the retroperitoneal primary tumor is MIBG- or FDG-PET-positive)
- •(3) PD (per INRC 2017) at study enrollment
- •(4) Has a functional disorder (CTCAE Grade 3 or higher) of a major organ. However, this does not include deafness, hematological status, renal function, or hepatic function.
- •(5) Has a life-threatening active infection
- •(6) Patients whose hepatitis virus test results at screening fall under any of the following
- •Patients positive for either HBs antigens or HCV antibodies. However, patients who are HCV antibody positive but have no detectable HCV-RNA are allowed to participate.
- •Patients who are HBs antigen-negative, have positive HBs antibodies or HBc antibodies, and positive quantitative tests for HBV-DNA (if HBV-DNA is less than detectable, they can participate in the study).
- •(7) Has received NPC-33
- •(8) Has a Karnofsky score (at least 16 years of age) or a Lansky score (15 years of age or younger) of less than 50
- •(9) Women who are pregnant, may be pregnant, or are breastfeeding. The possibility of pregnancy will be determined by a pregnancy test plus physician interviews, etc. Considering the possibility of amenorrhea due to treatment with antineoplastic agents, etc., a pregnancy test will be performed even for patients who have been amenorrheic for 12 months or longer if the possibility of pregnancy cannot be ruled out. Breastfeeding women are not allowed to stop breastfeeding and participate in the study. (If breastfeeding is discontinued at the time of obtaining informed consent and it is confirmed that there is no plan to resume breastfeeding after completion of administration of the investigational drug, participation in this study is permitted.)
- •(10) Men or women of childbearing potential who do not agree to use contraception for 42 days after the last dose of NPC-33*
- •Women of childbearing potential: Women who have experienced menarche, have not had permanent contraception, and are not menopausal. Menopause is defined as the absence of menses for at least 12 months without other medical reasons such as medication administration.
- •(11) Unable to comply with the protocol
- •(12) Has a history of hypersensitivity to any ingredients of NPC-26sc, yeast-derived products, or study medications
- •(13) Has a history of CTCAE Grade 4 anaphylaxis in response to anti-GD2 antibodies
- •(14) Has neuroblastoma of the central nervous system diagnosed within 6 months of the first dose of NPC-26sc
- •(15) Has received allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion under the following circumstances:
- •Within 6 months of the first dose of NPC-26sc
- •Lymphocyte count < 200/micro L
- •(16) Received allogeneic stem cell (lymphocyte removal) boost (HPC) within 2 months of the first dose of NPC-26sc
- •(17) Has received or plans to receive an immunosuppressant (other than local administration of steroids) within 1 month of the first dose of NPC-26sc
- •(18) Has disqualifying cardiac function (left ventricular ejection fraction < 50% as determined by echocardiography, or other heart disease that investigators deem to be clinically problematic)
- •(19) Has otherwise been deemed ineligible by investigators
结局指标
主要结局
-
All treatment-emergent adverse events (TEAEs) occurring before the end of Cycle 1
次要结局
未报告次要终点
研究者
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