A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 13
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
研究概览
简要总结
TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.
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
- •Patient is > 18 years of age at the time the Informed Consent is signed.
- •Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
- •Patient's tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
- •Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
- •Patients has an ECOG performance status 0 or 1
- •Patient is fit for leukapheresis and has adequate venous access for the cell collection.
- •Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
排除标准
- •Inability to follow the procedures of the study
- •Known or suspected non-compliance, drug, or alcohol use
研究组 & 干预措施
Lymphodepletion followed by TC-510
Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
干预措施: TC-510 (Biological)
Lymphodepletion followed by TC-510
Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
干预措施: Fludarabine (Drug)
Lymphodepletion followed by TC-510
Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
时间窗: From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
次要结局
- Overall Response Rate (ORR)(From first TC-510 infusion through study completion (up to approximately 38 months))
- Disease Control Rate (DCR)(From first TC-510 infusion through study completion (up to approximately 38 months))