2023-508601-24-00已完成2 期
A Phase 1/2 Study of REGN7257 (Anti-Interleukin 2 Receptor Subunit Gamma [IL2RG] Monoclonal Antibody) in Patients with Severe Aplastic Anemia that is Refractory to or Relapsed on Immunosuppressive Therapy
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Part A: Incidence of adverse events (AEs), incidence of serious adverse events (SAEs), and incidence and severity of treatment-emergent adverse events (TEAEs);
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of REGN7257 in patients with IST-refractory or IST-relapsed SAA. An additional primary objective (for Part B only) is to evaluate the clinical efficacy of REGN7257 in patients with IST-relapsed SAA as proof of concept
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Part A: SAA that is IST-refractory or IST-relapsed, as defined in the protocol
- •Part B: SAA that is IST-relapsed, as defined in the protocol
- •Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient
- •Adequate hepatic and renal function as defined in the protocol
- •Other protocol-defined inclusion criteria apply
排除标准
- •Diagnosis of Fanconi anemia or other congenital bone marrow failure syndrome as defined in the protocol
- •Other protocol-defined exclusion criteria apply
- •Evidence of myelodysplastic syndrome as defined in the protocol
- •Paroxysmal nocturnal hemoglobinuria (PNH) with evidence of clinically significant hemolysis (eg, treatment indicated) or history of PNH-associated thrombosis
- •Treatment with a T cell-depleting agent (eg, ATG or alemtuzumab) within 6 months prior to dosing
- •Treatment with a calcineurin inhibitor (eg, cyclosporine) within 4 weeks prior to dosing for patients enrolled in Part A
- •Treatment with eltrombopag or investigational thrombopoietin receptor agonist, Granulocyte Colony-Stimulating Factor (G-CSF), or an androgen (eg, danazol), within 2 weeks prior to dosing
- •HIV, hepatitis B or hepatitis C positive by serological testing at the screening visit as defined in the protocol
- •Active tuberculosis, latent tuberculosis infection (LTBI) or history incompletely-treated tuberculosis or LTBI
- •Active infection as defined in the protocol
结局指标
主要结局
Part A: Incidence of adverse events (AEs), incidence of serious adverse events (SAEs), and incidence and severity of treatment-emergent adverse events (TEAEs);
Part A: Incidence of adverse events (AEs), incidence of serious adverse events (SAEs), and incidence and severity of treatment-emergent adverse events (TEAEs);
Part B: Incidence of serious adverse events (SAEs), incidence and severity of treatment-emergent adverse events (TEAEs);
Part B: Incidence of serious adverse events (SAEs), incidence and severity of treatment-emergent adverse events (TEAEs);
Part B: Overall response rate (ORR);
Part B: Overall response rate (ORR);
次要结局
- Any clinical response; Part A
- Any clinical response; Part B
- Changes in reticulocyte cell counts; Part A
- Overall response rate (ORR); Parts A & B
- Complete response (CR); Parts A and B
- Partial response (PR); Parts A and B
- Time to best response; Part A
- Time to best response; Part B
- Time to first response; Part A
- Time to first response; Part B
- Platelet transfusions per month over time; Part A
- Platelet transfusions per month over time; Part B
- Red blood cell transfusions per month over time; Part A
- Red blood cell transfusions per month over time; Part B
- Changes in lymphocyte cell counts; Part A
- Changes in lymphocyte cell counts; Part B
- Changes in neutrophil cell counts; Part A
- Changes in neutrophil cell counts; Part B
- Changes in hemoglobin cell counts; Part A
- Changes in hemoglobin cell counts; Part B
- Changes in reticulocyte cell counts; Part B
- Changes in platelet cell counts; Part A
- Changes in platelet cell counts; Part B
- Changes in the whole blood immune cell subsets (T cells); Part A
- Changes in the whole blood immune cell subsets (T cells); Part B
- Changes in the whole blood immune cell subsets (B cells); Part A
- Changes in the whole blood immune cell subsets (B cells); Part B
- Changes in the whole blood immune cell subsets [Natural killer (NK) cells]; Part A
- Changes in the whole blood immune cell subsets (NK cells); Part B
- Drug concentrations in serum over time; Part A
- Drug concentrations in serum over time; Part B
- Incidence of treatment-emergent anti-drug antibody (ADA) over time; Part A
- Incidence of treatment-emergent ADA over time; Part B
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (1)
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