CTIS2023-503281-23-00进行中（未招募）1 期
A seamless Phase I/II trial with an initial open-label dose escalation part and a subsequent randomised, double-blind, placebo-controlled expansion part to evaluate the safety, tolerability, and efficacy of a single dose of BI 3720931, an inhaled lentiviral vector gene therapy, in adult people with cystic fibrosis who are ineligible for CFTR modulators (LenticlairTM 1) - 1504-0001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female of non-childbearing potential trial participants with a CF-pulmonary phenotype and a confirmed diagnosis of CF: - Positive sweat chloride =60 mEq/L by pilocarpine iontophoresis OR - Genotype with 2 identifiable CF-causing mutations accompanied by one or more clinical features if sweat chloride testing is between 30 and 59 mmol/L, Trial participants who are not eligible for treatment with CFTRmt due to their genotype with 2 identified CFTR-mutations (including Class I CFTR gene mutations) and are also not expected to become eligible during the trial according to investigator´s opinion, Trial participants able to perform acceptable spirometric maneuvers according to American Thoracic Society/European Respiratory Society 2019 standards, FEV1pp =50% and =100% of predicted normal at Visit 1. Predicted value based on Global Lung Initiative lung function reference equations, Stable CF disease with no pulmonary exacerbation 4 weeks prior to the screening visit and during the screening period and stable drug- and non-drug therapy for CF in the 4 weeks prior to dosing, Trial participants either naïve to prior gene therapy or exposed to prior viral or non-viral gene therapies for cystic fibrosis. If prior exposure to gene therapy for CF exists, then the following applies as per investigator judgement: a. No apparent residual side effects associated with prior gene therapy as per investigator assessment, and b. Drug-free interval of -- 6 months after last dose of prior non-viral gene therapy -- 24 months after last dose of prior viral gene therapy, Further inclusion criteria apply.
排除标准
- •Trial participants with ongoing or planned treatment with any CFTRmt, Trial participants with ongoing or planned CFTRmt, or participants not eligible for CFTRmt based on contraindications (e.g. liver failure) or who needed to withdraw CFTRmt due to intolerability are not appropriate candidates for this Phase I/II trial, Trial participants requiring chronic use of systemic corticosteroids or immunosuppressants to treat another condition, Further exclusion criteria apply.
研究者
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