A Phase 1, Open-Label Study of the Safety, Tolerability and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) as a Single Agent and in Combination With Approved Immune Checkpoint Inhibitors in Patients With Relapsed/ Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Number Of TEAEs By The Dose Of iNKT Cell Therapy
研究概览
简要总结
This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed/refractory (r/r) solid tumors, as well as define the recommended phase II dose in solid tumors. This Phase 1 study will also explore the safety, tolerability, and preliminary clinical activity of agenT-797 in combination with approved immune checkpoint inhibitors (ICIs), including pembrolizumab and nivolumab, in participants with r/r solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histological or cytological evidence of relapsed or refractory solid tumor malignancy for which no standard therapy is available or standard therapy has failed
- •Measurable disease per RECIST 1.1 as assessed by local site Investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- •Part 2 only, participants must have progressed per Investigator assessment on pembrolizumab or nivolumab, and agree and are able to continue on the inhibitor(s) while on study
- •No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the Principal Investigator
排除标准
- •Concurrent invasive malignancy
- •Brain and/or leptomeningeal metastases that are untreated or require current therapy
- •Prior radiotherapy within 2 weeks of start of study treatment
研究组 & 干预措施
Part 2: agenT-797 in Combination with approved ICIs
Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care
干预措施: agenT-797 (Drug)
Part 1: Monotherapy with agenT-797
3+3 Dose escalation of agenT-797 will be administered as a single intravenous (IV) infusion.
干预措施: agenT-797 (Drug)
Part 2: agenT-797 in Combination with approved ICIs
Single prespecified dose of agenT-797 administered by IV infusion in combination with approved ICIs administered in accordance with manufacturer instructions and institutional guidelines as per standard of care
干预措施: Approved ICIs (Drug)
结局指标
主要结局
Number Of TEAEs By The Dose Of iNKT Cell Therapy
时间窗: Baseline through 12 months
This will be determined according to the NCI CTCAE v5.0.
Number Of Dose-limiting Toxicities
时间窗: Baseline through first 14 days after administration
Number Of Adverse Events (AEs) By The Dose Of iNKT Cell Therapy
时间窗: Baseline through 12 months
This will be determined according to the NCI CTCAE v5.0.
Severity Grade Of AEs By Dose Of iNKT Cell Therapy
时间窗: Baseline through 12 months
This will be determined according to the NCI CTCAE v5.0.
Number Of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline through 12 months
This will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
次要结局
- Persistence Of agenT-797 In Peripheral Blood Samples(Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0.5, 1, 2, and 4 hours after cell infusion), and on Days 2, 5, 8, 15, 22, and 29; Weeks 6, 8, and 12; and Months 6, 9, and 12)
- Objective Response Rate (ORR)(Up to 12 months)
- Progression-free Survival (PFS)(Up to 12 months)
- Incidence Of Donor-specific Antibody(Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months))
- Duration Of Response (DOR)(Up to 12 months)
- Incidence Of Panel-reactive Antibody(Baseline/Day 1 (pre-infusion), Day 8, Day 15, Day 29, Week 8, Week 12, Month 6, and end of study visit (up to 12 months))