NCT03692429招募中1 期
An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Occurence of Dose Limiting Toxicities
研究概览
简要总结
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
详细描述
This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer
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
- •Histologically proven metastatic adenocarcinoma of the colon or rectum.
- •Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum.
- •Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease.
- •Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
- •FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy.
- •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.
- •The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •The patient must have adequate bone marrow reserve, hepatic, renal, pulmonary and cardiac functions.
排除标准
- •The patient has a confirmed or history of tumor involvement in the central nervous system (CNS).
- •Any non-cancer-directed investigational agent within 3 weeks before the planned day for the first CYAD-101 administration.
- •Filgrastim (Granulocyte-Colony-Stimulating Factor [G-CSF]) or similar growth factors within 7 days before the planned day for the first CYAD-101 administration.
- •Prior allogeneic stem cell transplantation, chimeric antigen receptor therapy or other genetically modified T-cell therapy.
研究组 & 干预措施
CYAD-101 with FOLFOX
Experimental
Infusion after standard FOLFOX chemotherapy
干预措施: CYAD-101 (Drug)
CYAD-101 with FOLFOX
Experimental
Infusion after standard FOLFOX chemotherapy
干预措施: FOLFOX (Drug)
CYAD-101 with FOLFIRI
Experimental
Infusion after standard FOLFIRI chemotherapy
干预措施: CYAD-101 (Drug)
CYAD-101 with FOLFIRI
Experimental
Infusion after standard FOLFIRI chemotherapy
干预措施: FOLFIRI (Drug)
结局指标
主要结局
Occurence of Dose Limiting Toxicities
时间窗: Up to 82 days post first CYAD-101 Infusion
次要结局
未报告次要终点
研究者
研究点 (4)
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