Treatment of Advanced or Metastatic Triple-negative Breast Cancer With Adoptive Therapy of PD1+ Tumor-infiltrating Lymphocytes (TILS001 Trial)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Incidence of grade 3-5 adverse event (AE)
研究概览
简要总结
This is a prospective, multicenter, phase I/II, open-label, two-stage design of PD1+ TILs infusion in metastatic or advanced TNBC. TILS001 includes 3 parts. Previous to each phase inclusion, a specific ICF must be signed by the patient. Participants potentially eligible to participate in the clinical trial will be offered to sign a ICF three times prior to TILs treatment: 1) to allow for collection of archival FFPE tissue samples for determination PD1 by mRNA (Part #1), 2) prior to a fresh metastatic biopsy for selection, isolation and partial expansion of PD1+ TILs (Part #2) and 3) prior to allow for remaining study procedures and TILs therapy (Part #3, Main Consent).
详细描述
This trial has been developed in TNBC, a breast cancer subtype with a particularly poor prognosis. The product used for treating participating patients will be selected PD1-positive TILs. Such TILs will be manufactured in Hospital Clinic under the name of NUMARZU-001. The procotol has been designed in three parts to better select participating patients. Molecular pre-screening has been established to select tumors with a higher probability of enrichment by PD1-positive TILs. The pre- screening consists of performing a tumor biopsy and selecting isolation and expansion of PD1- postive TILs to manufacture the final product NUMARZU-001. This part could last almost four weeks, as such patients will continue with the established treatment in the meanwhile. Finally, NUMARZU-001 will be administered if the patient is eligible for part three of the protocol.
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
PD1+ TILs (NUMARZU-001) product infusion
The treatment administration is divided in NMA-LD chemotherapy(auxiliary medication), TILs product (IMP) and IL-2 (auxiliary medication).
干预措施: PD1+ TILs (NUMARZU-001) product infusion (Drug)
结局指标
主要结局
Incidence of grade 3-5 adverse event (AE)
时间窗: 24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)
Incidence of grade 3-5 adverse event (AE) assessed by the NCI Common Terminology for Classification of Adverse Events (CTCAE) version 5.0, and any grade AE assessed by CTCAE that leads to treatment discontinuation and possibly related to treatment, that occur in the first 24h following PD1+ TILs infusion (prior to IL-2 treatment). * Incidence of grade 3-5 AEs assessed by the NCI CTCAE version 5.0 taking into account the whole process, which includes NMA-LD chemotherapy followed by TILs infusion and at least one dose of IL-2 treatment. * All changes in treatment administration including delays, interruptions, reductions or discontinuation and the main reason(s) for these changes.
Overall response rate (ORR)
时间窗: 24 weeks from the administration of PD1+ TILS (NUMARZU-001 product)
Overall response rate (ORR) locally determined as the best response (defined as CR and PR) by the investigator according to RECIST 1.1 criteria from the administration of PD1+ TILS (NUMARZU-001 product); on day 0
次要结局
- Duration of Response (DoR)(24 weeks from the administration of PD1+ TILS (NUMARZU-001 product))
- Overall Survival (OS)(From completion of the Response Assessment Period and up to 5 years from the last study treatment until death, loss to follow-up, or withdrawal of consent)
- Progression-Free Survival at 6 months(PFS6)(24 weeks from the administration of PD1+ TILS (NUMARZU-001 product))
- Clinical Benefit Rate at 6 months (CBR6)(24 weeks from the administration of PD1+ TILS (NUMARZU-001 product))
- Progression-free survival (PFS)(24 weeks from the administration of PD1+ TILS (NUMARZU-001 product))