NCT07738822尚未招募1 期
A Phase 1b/2a, Open-label Study of Velinotamig for the Treatment of Adults With Relapsing and Refractory Immune Thrombocytopenia and Warm Autoimmune Hemolytic Anemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA) to evaluate safety and tolerability.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 to 80 years
- •Active autoimmune cytopenia
- •Relapsed/refractory after standard of care therapy
- •ECOG performance status 2 or lower
- •Laboratory parameters including the following:
- •Absolute lymphocyte count (ALC) ≥0.5 × 109/L
- •Absolute neutrophil count (ANC) ≥1.0 × 109/L
- •Hemoglobin ≥6.5 g/dL
- •Total bilirubin ≤1.5 × ULN unless related to Gilbert's syndrome
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0 × ULN, unless attributable to hemolysis
- •Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥30 mL/min/1.73m2
排除标准
- •Pregnant or lactating women
- •History of clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with subject safety, study evaluations, and/or study procedures, would put the patient at undue risk or confound study results
- •Evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV), HIV, Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection
- •Active or latent tuberculosis (TB) evidenced by a positive or indeterminate interferon gamma release assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB
- •Presence of New York Heart Association class III or IV congestive heart
- •Primary immunodeficiency or history of recurrent infections
- •Previous treatment with a BCMA-targeted therapy
- •Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1
- •History of solid organ transplant
- •Planned major surgery in the timeframe of the dosing period
结局指标
主要结局
Safety and Tolerability
时间窗: 48 weeks
Incidence and severity of all adverse events, serious adverse events, adverse events of special interest, adverse events leading to treatment discontinuation, and laboratory abnormalities.
次要结局
未报告次要终点
研究者
研究点 (1)
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