jRCT2033210499招募中不适用
An Open-Label Non-Randomized Phase 1 Dose Escalation and Dose Expansion Study of NIB101 in Participants with Advanced Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 主要终点
- DLTs
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
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant with histologically or cytologically confirmed solid tumor.
- •Participants who failed or are intolerable to available standard of cares (regardless of the number of prior lines of therapy) at the investigator's discretion.
- •Participant whose tumor tissues express GM2 membrane as determined by immunohistochemistry.
- •Participant who has measurable lesions.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Life expectancy >=12 weeksfrom the signing screening ICF.
- •Participant with adequate organ functions.
- •Participant who can undergo apheresis at the investigator's discretion.
- •Participant must agree to use adequate contraception methods
- •Patipant who is willing to sign a written informed consent.
排除标准
- •Active brain metastasis on the screening MRI (in case of MRI contradiction, CT is acceptable).
- •Participant with an active, known or suspected autoimmune disease requiring immune suppressive agents other than hormonal replacement therapy.
- •Prior malignancy (other than targeted GM2 positive malignancy) within the previous 3 years the signing screening ICF.
- •Suspected malignant lymphoma or leukemia
- •Participant with known or suspected interstitial pneumonia
- •Active infections requiring treatments
- •Participant with an active, known or suspected gangliosidosis.
- •Other concurrent serious diseases that may interfere with planned study intervention per investigator's discretion.
- •Prior treatment with engineered T-cell therapy/gene therapy.
- •Prior treatment with any GM2, IL-7 or CCL19 targeted therapy.
- •Participant with a condition requiring systemic treatment with either corticosteroids (>= 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to apheresis. Inhaled or topical steroids, and adrenal replacement steroid doses <10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •Participant with adverse events due to prior therapy have not recovered to grade 1 or baseline, except for non-clinically significant adverse events at the investigator's discretion such as alopecia.
- •Anti-neoplasm treatment within 14 days prior to apheresis
- •Radiation therapy within 14 days prior to apheresis
- •Participant currently requiring ganciclovir, valganciclovir, and so on (the drug that provides HSV-TK substrate) treatment. Participants currently receiving prophylaxis treatment can be enrolled if the prophylaxis treatment is completed before apheresis.
- •Major surgery within 4 weeks prior to screening informed consent.
- •Prior treatment with any investigational study drug/investigational study cell and gene therapies within 28 days before signing screening ICF.
- •Positive human immunodeficiency virus (HIV) and/or HTLV-1 antibody test on the screening prior to apheresis.
- •Positive HBsAg or HCV antibody test on the screening prior to apheresis. Participant who has positive HBs antibody or HBc antibody can be enrolled if HBV-DNA is undetectable.
- •Any symptoms of suspected syphilis
- •Pregnant or breastfeeding
- •History of allergy or hypersensitivity to components of NIB101 or materials used for manufacturing NIB
- •Hypersensitivity or contraindicated to study intervention components.
结局指标
主要结局
DLTs
时间窗: Dose escalation phase
Dose-limiting toxicities
SAEs
时间窗: Dose escalation phase, Dose expansion phase
Serious adverse events
AEs leading to discontinuation
时间窗: Dose escalation phase, Dose expansion phase
Adverse events leading to discontinuation
AEs of special interest
时间窗: Dose escalation phase, Dose expansion phase
Adverse events of special interest
AEs
时间窗: Dose escalation phase, Dose expansion phase
Adverse events
次要结局
未报告次要终点
研究者
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