Adoptive therapy with TCR gene-engineered T cells to treat patients with MAGE-C2-positive melanoma and head and neck cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Phase I: AEs according to CTCAE 5.0
研究概览
简要总结
Phase I: To study the safety and feasibility of AT with autologous MC2 TCR T cells, combined with epigenetic drug treatment, in patients with advanced melanoma or HNSCC. Adverse events (AEs) will be documented according to CTCAE v5.0. To define the maximum tolerated dose (MTD) of MC2 TCR T cells in the combination treatment. Phase II: To assess the efficacy of AT with autologous MC2 TCR T cells at MTD, combined with epigenetic drug treatment, in patients with advanced melanoma or HNSCC. Tumor response will be evaluated using RECIST v1 .1.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 years of age.
- •inoperable stage Ille or stage IV cutaneous melanoma, including ocular or mucosal melanoma, progressing after standard of care therapy, or recurrent/metastatic HNSCC
- •Patients must be HLA-A2 positive.
- •The primary tumor and/or metastasis have to be positive for MAGE-C2
- •Patients must have a clinical performance status of ECOG O or 1
- •Patients of both genders must be willing to practice a highly effective method of birth control during treatment and for four months after receiving the preparative regime
- •Patients must be able to understand and sign the Informed Consent document.
排除标准
- •Life expectancy of less than three months.
- •Requirement for systemic steroid therapy
- •Patients who have active/symptomatic CNS metastases
- •Patients with pleural effusion or ascites.
结局指标
主要结局
Phase I: AEs according to CTCAE 5.0
Phase I: AEs according to CTCAE 5.0
Phase I: Recommended Phase II dose
Phase I: Recommended Phase II dose
Phase I: Feasibility to deliver this sequence of treatmen
Phase I: Feasibility to deliver this sequence of treatmen
Phase II: Objective response rate according to RECIST v1 .1
Phase II: Objective response rate according to RECIST v1 .1
Phase II: PFS
Phase II: PFS
Phase II: OS
Phase II: OS
次要结局
- Phase I and II: Persistence and function of MC2-specific T cells in peripheral blood.
- Phase I and II: Systemic release of inflammatory cytokines after administration of autologous MC2 TCR T cells
- Phase I and II: Immune parameters, in particular T cell parameters, in blood and tumor tissues (when available) prior to and during treatmen
- Phase I and II: Global DNA hypomethylation and histone acetylation in PBMCs after epigenetic treatment and administration of autologous MC2 TCR T cells
研究者
Astrid van der Veldt
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)