A Phase I/II Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in patients with relapsed or refractory multiple myeloma.
详细描述
The purpose of this study is to evaluate the safety, determine the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and characterize the immunogenicity and pharmacokinetic profile of ALT-803 in treated patients. The effect of ALT-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells will be evaluated. The anti-tumor responses of ALT-803 will also be assessed in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1: N-803 - IV 1 ug/kg
干预措施: N-803 (Biological)
Cohort 2: N-803 - IV 3 ug/kg
干预措施: N-803 (Biological)
Cohort 3: N-803 - IV 6 ug/kg
干预措施: N-803 (Biological)
Cohort 4: N-803 - IV 10 ug/kg
干预措施: N-803 (Biological)
Cohort 5: N-803 - SQ 10 ug/kg
干预措施: N-803 (Biological)
Cohort 6: N-803 - SQ 15 ug/kg
干预措施: N-803 (Biological)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: 24 weeks
For phase I - Number of Participants with Treatment Emergent Adverse Events that occur or worsen after the first dose of study treatment.
Disease Response Rate of Treated Patients
时间窗: Starts at Week 11 - 12 and Week 23 - 24
CR- negative SIFE and UIFE, disappearance of any soft tissue plasmacytomas, and \< or = to 5% plasma cells in bone marrow VGPR - either + SIFE and UIFE and - SPEP and UPEP or reduction in serum M-protein \> or = to 90% and urine m-protein level \<100mg per 24h PR - if measurable serum an urine m-protein them reduction of serum m-protein by \>=50% and reduction in 24h urinary m protein by \>=90% or to \<200mg per 24h if unmeasurable serum and urine m-protein then \>= 50% decrease in the difference between involve and uninvolved FLC levels If unmeasurable serum and urine m-protein and serum FLC assay then \>= 50% reduction in plasma cells, provide baseline bone marrow plasma cell percentage was \>=30% In addition to the above listed criteria, if present at baseline, a \>=50% reduction in the size of soft tissue plasmacytomas is also required PD - defined via International Myeloma Working Group uniform response criteria: disease progression SD - not meeting criteria for CR, VGPR, PR or PD
次要结局
- Characterization of the Pharmacokinetic Profile - Half-life (t½)(PK timepoint up to 72 hours +/- 6 hours)
- Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax)(PK timepoint up to 72 hours +/- 6 hours)
- Characterization of the Pharmacokinetic Profile - Maximum Observed Concentration (Cmax)(PK timepoint up to 72 hours +/- 6 hours)
- Characterization of the Pharmacokinetic Profile - Area Under the Plasma Concentration Curve(Samples were collected and the AUC was determined at 24 hours and at time t (last measurable concentration). The AUC was calculated for 168 hours and time to infinity.)
- Characterization of the Pharmacokinetic Profile - Clearance (CL)(PK timepoint up to 72 hours +/- 6 hours)
- Characterization of the Pharmacokinetic Profile - Vss Volume of Distribution at Steady State(PK timepoint up to 72 hours +/- 6 hours)
- Immunogenicity - Anti-drug Antibody (ADA)(From Baseline up to Week 12)
- Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F)(PK timepoint up to 72 hours +/- 6 hours)
- Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Volume of Distribution (Vz/F)(PK timepoint up to 72 hours +/- 6 hours)