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

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

NKR-2 cells

Tags

MSS/ MMRp

Comments

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

Location Location Status
Belgium
Institut Jules Bordet
Brussels 1000
Active, not recruiting
Cliniques universitaires Saint-Luc
Brussels 1200
Active, not recruiting
Grand Hôpital de Charleroi
Charleroi 6000
Active, not recruiting
UZ Leuven
Leuven 3000
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

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

Exclusion Criteria

Exclusion Criteria:

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

Date Trial Added

2017-10-16

Updated Date

2020-06-16