NCT05050006终止2 期
A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Instil Bio
- 入组人数
- 29
- 试验地点
- 44
- 主要终点
- Objective response rate
研究概览
简要总结
DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. 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 confirmed advanced (unresectable or metastatic) cutaneous melanoma.
- •Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
- •Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- •Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- •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
- •Melanoma of uveal, acral, or mucosal origin
- •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, or IL-2.
结局指标
主要结局
Objective response rate
时间窗: Up to 60 months
Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review.
次要结局
- Overall Survival(Up to 60 months)
- Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest(Up to 60 months)
- ORR as determined by investigators(Up to 60 months)
- Progression-free Survival(Up to 60 months)
- Duration of Response(Up to 60 months)
- Best Overall Response(Up to 60 months)
- Disease Control Rate(Up to 60 months)
- Time to Response(Up to 60 months)
研究者
研究点 (44)
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