NCT04956744进行中（未招募）1 期
A Phase 1, Dose-Escalating, Open-label Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of Single Dose of IV IMS001 in Subjects With Multiple Sclerosis and Treatment Failure to Prior Disease Modifying Treatments (DMTs)
ImStem Biotechnology6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a Phase 1 study of IMS001, given as a single dose to subjects with Multiple Sclerosis who experience inadequate response and/or intolerability to disease modifying treatments. IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC). MSCs have the potential to modulate disease course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides signed and dated informed consent in accordance with local regulations.
- •18 to 65 years of age.
- •Diagnosis of MS.
- •Has had an inadequate response DMTs.
- •EDSS within protocol parameters.
- •Able and willing to undergo MRIs.
- •Must be clinically stable for 1 month prior to Day 1.
排除标准
- •Has a known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS
- •Has history of excluded medications, per protocol, prior to Day
- •Has a history of neoplastic disease except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin that has been excised with clean margins, or adequately treated in-situ carcinoma of the cervix.
- •Prior history of any other autoimmune disease, myelodysplasia, or hematologic disease.
- •Prior treatment with any allogeneic cell therapy or tissue transplant.
- •Prior history of smoking equivalent to ˃20 cumulative pack years of cigarettes.
- •Recent clinically significant infection during the Screening Phase.
- •Has any medical or psychiatric condition that would impact outcome or participation in the study.
- •Has clinically significant abnormal findings on the electrocardiogram (ECG) during the Screening Phase.
- •Has known or documented human immunodeficiency virus (HIV) infection or active Hepatitis B, or C.
- •Has an elevated liver function test abnormality during the Screening Phase.
- •Has abnormalities of blood count during the Screening Phase.
- •Has laboratory abnormalities of renal function during the Screening Phase.
- •Has other clinically significant laboratory abnormalities during Screening Phase.
- •Body weight ≥120 kg.
- •Women pregnant, breast feeding, or planning to become pregnant during the study.
- •Is unavailable for the duration of the trial, is likely to be noncompliant with the protocol, or is generally felt to be unsuitable by the principal investigator.
- •Current or recent participation in any other clinical or device trials within 3 months prior to Day 1.
研究组 & 干预措施
Low Dose
Experimental
Low dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
干预措施: IMS001 (Biological)
Optional Dose
Experimental
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1 and at Month 6.
干预措施: IMS001 (Biological)
High Dose
Experimental
High dose of cells/kg of intravenous (IV) IMS001 as a single dose infusion on Day 1.
干预措施: IMS001 (Biological)
结局指标
主要结局
Safety and tolerability
时间窗: Day 1 to Month 60
Frequency of treatment-emergent adverse events (TEAEs).
次要结局
未报告次要终点
研究者
研究点 (6)
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