NCT07593911尚未招募不适用
An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)
Beijing GoBroad Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
研究概览
简要总结
This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related autoimmune diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Key inclusion criteria include：
- •Male or female, aged 18 - 75 years old (inclusive);
- •The participant or his/her legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;
- •Confirmed diagnosis of the target autoimmune disease per international classification criteria;
- •Adequate organ function to tolerate treatment;
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.
排除标准
- •Key exclusion criteria include:
- •Active, severe, uncontrolled infection;
- •Pregnancy or breastfeeding women;
- •History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;
- •Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.
研究者
研究点 (1)
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