NCT05994157终止1 期
Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 6
- 主要终点
- Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
研究概览
简要总结
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.
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
- •Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
- •The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
- •CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
- •Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- •Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.
排除标准
- •Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
- •Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
- •Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
- •Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
- •Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
- •>40% lymphoma bone marrow involvement
研究组 & 干预措施
CD38-SADA:177Lu-DOTA Complex
Experimental
干预措施: CD38-SADA:177Lu-DOTA Complex (Drug)
结局指标
主要结局
Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
时间窗: 4 weeks
Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (6)
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