肿瘤细胞治疗研究
英文原题：alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
⚠ 该试验的登记信息已有 71 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I 期注册临床试验，评估细胞治疗用于结直肠癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 49 例。试验地点：美国 · 坦帕、布鲁塞尔、埃德海姆、鲁汶（共 4 个中心）。登记号：NCT03692429。
不限性别 · ≥ 18 Years
纳入标准： 1. 组织学证实的结肠或直肠转移性腺癌。 1. 确诊的不可切除的结肠或直肠转移性腺癌。 2. 针对转移性疾病至少接受过一线全身治疗后复发/进展。 3. 根据实体瘤疗效评价标准（RECIST 1.1版）具有明确且可测量的病灶。 4. FOLFOX组：既往化疗引起的神经毒性小于或等于常见不良事件评价标准（CTCAE）1级。 5. FOLFIRI组：在研究入组前3个月内，接受FOLFIRI治疗（联合或不联合靶向治疗）期间记录到疾病进展（PD）。若在研究入组前FOLFIRI记录PD后接受过抗癌治疗，只要在计划研究入组前至少7天停止，则允许。不允许放疗。 2. 患者必须具有东部肿瘤协作组（ECOG）体能状态评分0或1。 3. 患者必须具有足够的骨髓储备，以及充分的肝、肾、肺和心脏功能。 排除标准： 1. 患者确诊或有中枢神经系统（CNS）肿瘤受累史。 2. 在计划首次给予CYAD-101前3周内使用过任何非针对癌症的研究性药物。 3. 在计划首次给予CYAD-101前7天内使用过非格司亭（粒细胞集落刺激因子[G-CSF]）或类似生长因子。 4. 既往接受过异基因干细胞移植、嵌合抗原受体治疗或其他基因修饰T细胞治疗。
Inclusion Criteria: 1. Histologically proven metastatic adenocarcinoma of the colon or rectum. 1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum. 2. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease. 3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). 4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy. 5. FOLFIRI segment: Documented progressive disease (PD) under FOLFIRI treatment, with or without targeted therapy, given within 3 months prior to study registration. Anti-cancer therapy post FOLFIRI-documented PD prior to study registration is authorized if discontinued at least 7 days before the planned study registration. Radiotherapy is not authorized. 2. The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 3. The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions. Exclusion Criteria: 1. The patient has a confirmed or history of tumor involvement in the central nervous system (CNS). 2. Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration. 3. Filgrastim (Granulocyte-Colony-Stimulating Factor \[G-CSF\]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration. 4. Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Occurence of Dose Limiting Toxicities · Up to 82 days post first CYAD-101 Infusion
标准化疗FOLFOX后输注
标准化疗FOLFIRI后输注
alloSHRINK研究的目的是评估CYAD-101在不可切除的转移性结直肠癌患者中，于标准化疗后给药的安全性、细胞动力学和临床活性。
The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy
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