A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601 (Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- ITB-Med LLC
- 入组人数
- 33
- 试验地点
- 7
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
研究概览
简要总结
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study requirements and provide written informed consent before and study assessment is performed.
- •Male or female patients ≥ 18 to 70 years of age.
- •Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor.
- •Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.
排除标准
- •Multiple-organ transplant recipients
- •Subjects who have received a kidney allograft previously
- •Recipient of a kidney from an HLA identical living related donor
- •Recipient of a kidney from a donor after cardiac death
- •Subjects at high immunological risk for rejection
研究组 & 干预措施
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: TCD601 (Biological)
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Tacrolimus (TAC) (Drug)
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Corticosteroids (CS) (Drug)
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Mycophenolate Mofetil (MMF) (Drug)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: TCD601 (Biological)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Tacrolimus (TAC) (Drug)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Corticosteroids (CS) (Drug)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Mycophenolate Mofetil (MMF) (Drug)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: TCD601 (Biological)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Tacrolimus (TAC) (Drug)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Corticosteroids (CS) (Drug)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Mycophenolate Mofetil (MMF) (Drug)
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: TCD601 (Biological)
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Tacrolimus (TAC) (Drug)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: ATG (Drug)
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Corticosteroids (CS) (Drug)
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Mycophenolate Mofetil (MMF) (Drug)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Tacrolimus (TAC) (Drug)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Corticosteroids (CS) (Drug)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
干预措施: Mycophenolate Mofetil (MMF) (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
时间窗: 12 months
Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.
时间窗: 12 months
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).
时间窗: 12 months
The AUC from time zero to the last measurable concentration sampling time.
次要结局
- The Incidence of Allograft Rejection at 12 Months Post-Transplant(12 months)
- To Assess Renal Function Over Time(12 months)