NCT07083960招募中1 期
An Open-Label, Phase 1b, Multiple Ascending Dose Study of OM336 in Participants With Active Autoimmune Cytopenias
Lakefront Biotherapeutics West LLC10 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2025年8月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 10
- 主要终点
- Safety and Tolerability
研究概览
简要总结
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
详细描述
An open-label, multicenter, ascending dose study, evaluating safety, tolerability, and PK/ADA of OM336 in autoimmune cytopenias.
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
- •Active autoimmune cytopenia
- •Relapsed/refractory after ≥1 prior treatment
- •Body weight ≥ 55 kg
- •Willing to comply with and study requirements and procedures
排除标准
- •Previous treatment with a BCMA-targeted therapy
- •Clinically significant infection within 3 months of screening
- •Major surgery or splenectomy within 3 months of screening or planned during the study
- •Pregnant or breastfeeding
研究组 & 干预措施
OM336 Dose Escalation
Experimental
Participants will receive OM336 via subcutaneous injection in ascending dose cohorts
干预措施: OM336 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 12 weeks
Incidence and severity of treatment emergent adverse events (TEAEs)
次要结局
- Safety and Tolerability(52 weeks)
- To assess the pharmacokinetics (PK) of OM336(12 weeks)
- Detection of anti-drug antibodies(12 weeks)
研究者
研究点 (10)
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相关资讯
Ouro Medicines' Gamgertamig Receives Second FDA Orphan Drug Designation for Immune Thrombocytopenia- Ouro Medicines announced that gamgertamig (OM336), a BCMAxCD3 T cell engager antibody, received FDA Orphan Drug Designation for immune thrombocytopenia (ITP) treatment.
- This marks the second orphan designation for gamgertamig, following previous approval for autoimmune hemolytic anemia, both conditions being evaluated in an ongoing Phase 1b basket study.
- The investigational bispecific antibody features a "detuned" CD3-targeting arm designed to minimize immune activation while maintaining target cell depletion potency.
- Dosing has been completed in the first cohort of the autoimmune cytopenias study, with results expected in 2026 and seven years of marketing exclusivity upon potential approval.9 months agoOuro Medicines Initiates Phase 1b Trial of OM336 in Autoimmune Cytopenias Following FDA Orphan Drug Designation- Ouro Medicines has launched a Phase 1b basket study of OM336, a BCMAxCD3 T cell engager, in autoimmune hemolytic anemia and immune thrombocytopenia across sites in the U.S. and Australia.
- The FDA granted OM336 Orphan Drug Designation for autoimmune hemolytic anemia treatment, providing regulatory benefits including seven years of marketing exclusivity.
- Previous case reports published in The New England Journal of Medicine showed two patients with relapsed/refractory AIHA achieved sustained remissions lasting at least six months without ongoing immunosuppression.
- OM336's unique "detuned" CD3-targeting design aims to avoid severe immune activation while maintaining target cell depletion potency, with over 80 patients dosed across multiple clinical trials.last year