A Phase 2, Multicenter, Open-label Study of Lifileucel (Tumor-infiltrating Lymphocytes [TIL]) in Participants With Previously Treated Advanced Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Objective Response Rate
研究概览
简要总结
A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA')
详细描述
The purpose of this study is to investigate the efficacy and safety of the lifileucel regimen in participants with previously treated soft tissue sarcoma. The length of the study for each participant may be up to 5 calendar years after receiving lifileucel. After Screening, each participant will have surgery to remove some tumor pieces that will be used to make the lifileucel, followed by a baseline visit prior to study treatment. Participants will then receive the lifileucel treatment regimen. This includes 2 drugs (cyclophosphamide and fludarabine) for up to 5 days to decrease lymphocytes in the body, the lifileucel infusion (1 day), and up to 4 days of aldesleukin to boost the activity of the lifileucel. Study visits will be every 6 weeks for 6 months, then every 3 months until 5 calendar years after the lifileucel infusion.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 16 years of age at the time of signing the informed consent and assent.
- •Participants who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
- •Participant must have a confirmed diagnosis of histologically confirmed unresectable or metastatic UPS (Cohort 1) or DDLPS (Cohort 2), with or without a well-differentiated component, who have received ≥ 1 and a maximum of 3 prior systemic therapies, including ≥ 1 anthracycline-based regimen.
- •Participant has demonstrated progressive disease on or after the last line of therapy.
- •Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for lifileucel generation.
- •Following tumor resection for lifileucel generation, the participant will have at least one measurable lesion, as defined by RECIST v1.1 at Baseline.
- •Participant is expected to achieve washout from investigational or anticancer therapy(ies).
- •If the participant has preplanned surgical procedure(s), the procedure will take place at least 14 days (for major operative procedures) prior to the tumor resection. Wound healing will have occurred, and all complications will have resolved at the time of tumor resection.
- •Participant has recovered from all prior anticancer treatment-related AEs to Grade ≤ 1(per NCI-CTCAE), except for peripheral neuropathy, alopecia, or vitiligo.
- •Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
- •Participants must have adequate organ function.
- •Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment.
排除标准
- •Participant has symptomatic untreated brain metastases.
- •The participant has an ECOG performance status of ≥ 2, a need for urgent therapy due to rapidly progressive disease or tumor mass effect, or an estimated life expectancy of< 6 months.
- •Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation.
- •Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
- •Participant has a history of hypersensitivity to any component of the study intervention.
- •Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated > 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence.
- •Other protocol defined inclusion/exclusion criteria could apply.
结局指标
主要结局
Objective Response Rate
时间窗: 5 years
To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC
次要结局
- Complete Response Rate(5 years)
- Duration of Response(5 years)
- Disease Control Rate(5 years)
- Progression-Free Survival(5 years)
- Objective Response Rate(5 years)
- Overall Survival(5 years)
- Adverse Events(5 years)