NCT05393635撤回1 期
A Phase 1, Open-Label, Multicenter Study Evaluating the Safety, Feasibility, and Preliminary Efficacy of ITIL-168 With Pembrolizumab in Subjects With Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Instil Bio
- 主要终点
- Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
研究概览
简要总结
DELTA-2 is a phase 1 clinical trial to evaluate the safety, feasibility, and preliminary efficacy of ITIL-168 with pembrolizumab in participants with advanced cancer whose disease has progressed after standard therapy. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
- •Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
- •Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
- •Cohort 3: Participants with NSCLC whose disease progressed during or after 1 prior line of platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have progressed on targeted therapy and platinum-based chemotherapy
- •Medically suitable for surgical resection of tumor tissue
- •Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate bone marrow and organ function
排除标准
- •History of another primary malignancy within the previous 3 years
- •Neuroendocrine carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the lip, or histopathology with neuroendocrine differentiation
- •Previously received an allogeneic stem cell transplant or organ allograft
- •Previously received TIL or engineered cell therapy (eg, CAR T-cell)
- •Significant cardiac disease
- •Stroke or transient ischemic attack within 12 months of enrollment
- •History of significant central nervous system (CNS) disorder
- •Symptomatic and/or untreated CNS metastases
- •History of significant autoimmune disease within 2 years prior to enrollment
- •Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, IL-2, of CPI
结局指标
主要结局
Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
时间窗: Up to 24 months
次要结局
- Progression-free Survival(Up to 60 months)
- Objective response rate(Up to 60 months)
- Duration of response(Up to 60 months)
- Overall Survival(Up to 60 months)
研究者
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