Dose Escalation and Dose Expansion Phase I Study to Assess the Safety and Clinical Activity of Multiple Doses of NKR-2 Administered Concurrently With FOLFOX in Colorectal Cancer With Potentially Resectable Liver Metastases

Estado del programa

Activo, no recluta

Fase

Fase 1

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

NKR-2 cells

Etiquetas

MSS/ MMRp

Comentarios

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

Ubicación Situación
Bélgica
Instituto Jules Bordet
Bruselas 1000
Activo, no recluta
Cliniques universitaires Saint-Luc
Brussels 1200
Activo, no recluta
Grand Hôpital de Charleroi
Charleroi 6000
Activo, no recluta
UZ Leuven
Lovaina 3000
Activo, no recluta

Criterios de inclusión

Criterios de inclusión:

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

Criterios de exclusión

Criterios de exclusión:

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

NCT ID

NCT03310008

Fecha en que se añadió el juicio

2017-10-16

Fecha de actualización

2020-06-16