NCT05737628进行中（未招募）1 期
First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination With Rituximab to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Relapsed/Refractory CD20 Positive B-cell Non-Hodgkin's Lymphoma (NHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Byondis B.V.
- 入组人数
- 17
- 试验地点
- 12
- 主要终点
- Incidence of dose-limiting toxicities
研究概览
简要总结
This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
详细描述
This study includes a dose escalation part (Part 1) in which the MTD and dose regimen for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.
BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part 1 (dose escalation): B-cell NHL expressing CD20 by immunohistochemistry (IHC) or flow cytometry, relapsed/refractory (R/R) to at least 2 prior lines of therapy.
- •Part 2 (dose expansion):
- •A. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) or Mantle Cell Lymphoma (MCL) expressing CD20 by IHC or flow cytometry, R/R to frontline therapy.
- •B. Histologically confirmed marginal zone or follicular lymphoma (Grade 1-3a) expressing CD20 by IHC or flow cytometry, R/R to at least 2 prior lines of therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- •Adequate organ function;
- •Laboratory measurements, blood counts (Growth Factor (GF) support and blood transfusions are not allowed within 2 weeks prior to this assessment):
- •Hemoglobin ≥ 8.5 g/dL (> 5.28 mmol/L);
- •Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/mL;
- •Platelet counts ≥ 50 × 10^9/mL;
排除标准
- •Having been treated with CD47 or SIRPα targeting agents at any time or other anticancer therapy within 4 weeks or as defined in the protocol;
- •History of hypersensitivity or allergic reaction to any of the excipients of BYON4228 or rituximab which led to permanent discontinuation of the treatment;
- •Burkitt's lymphoma;
- •Red blood cell (RBC) transfusion dependence;
- •Patients with active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD;
- •History of autoimmune hemolytic anemia or autoimmune thrombocytopenia;
- •History of active autoimmune disorders (including but not limited to: Crohn's disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave's disease) or other conditions that compromise or impair the immune system (except for hypogammaglobulinemia);
- •History (within 6 months prior to start IMP) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication;
- •Currently diagnosed or suspected CNS involvement;
- •Severe active infection or other severe uncontrolled systemic disease (e.g. advanced renal disease, pulmonary, uncontrolled diabetes mellitus, severely immunocompromised state, or metabolic disease)
研究组 & 干预措施
BYON4228 + Rituximab
Experimental
干预措施: BYON4228 + Rituximab (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities
时间窗: 28 days
Part 1
次要结局
- Objective response rate(2 years)
研究者
研究点 (12)
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