Status:
UNKNOWN
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
Lead Sponsor:
Celyad Oncology SA
Conditions:
Colon Cancer Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 admi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03310008
Start Date
August 7 2017
End Date
May 1 2021
Last Update
June 16 2020
Active Locations (4)
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1
Institut Jules Bordet
Brussels, Belgium, 1000
2
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
3
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000
4
UZ Leuven
Leuven, Belgium, 3000