计划状态
活跃，非招募阶段
第 1 阶段允许先接受免疫治疗
没有CRC 指导的试验
是药物
NKR-2 cells标签
MSS/ MMRp评论
Autologous NKR-2, also called NKG2D CAR-T cells and CYAD-01.
”SHRINK (Standard cHemotherapy Regimen and Immunotherapy with NKR-2) is an open-label Phase I study to assess the safety and clinical activity of multiple administrations of autologous NKR-2 cells administered concurrently with a standard chemotherapy treatment (FOLFOX) in potentially resectable liver metastases from colorectal cancer.”
* No previous chemotherapy for metastatic CRC,
* The patient is due to receive first-line metastatic chemotherapy regimen with FOLFOX as a neoadjuvant
Related trial: THINK NCT03018405 LINK NCT03370198
| 地点 | 位置状态 |
|---|---|
| 比利时 | |
|
儒勒-博尔代学院 布鲁塞尔 1000 |
活跃，非招募 |
|
Cliniques universitaires Saint-Luc Brussels 1200 |
活跃，非招募 |
|
Grand Hôpital de Charleroi Charleroi 6000 |
活跃，非招募 |
|
鲁汶工程大学 鲁汶 3000 |
活跃，非招募 |
纳入标准
纳入标准
Men or women ≥ 18 years old at the time of signing the ICF
Patients with histologically proven colorectal adenocarcinoma with potentially resectable liver metastases,
No previous chemotherapy for metastatic CRC,
The patient is due to receive first-line metastatic chemotherapy regimen with FOLFOX as a neoadjuvant
The patient must have an ECOG performance status 0 or 1
The patient must have sufficient bone marrow reserve, hepatic and renal functions
Detailed disease specific criteria exist and can be discussed with contacts listed below
排除标准
排除标准：
Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis
Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration
Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent, other than the treatment authorized per protocol
Patients who underwent major surgery within 4 weeks before the planned day for the first treatment
Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder
Patients who have received a live vaccine within 6 weeks prior to the planned day for the first NKR 2 administration
Patients with a family history of congenital or hereditary immunodeficiency
Patients with history of any autoimmune disease
