Status:
TERMINATED
Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer
Lead Sponsor:
Celyad Oncology SA
Conditions:
Colon Cancer Liver Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test an experimental anti-cancer immunotherapy called NKR-2 (modified T cells), to treat colorectal cancer with unresectable liver metastases. The trial will test three...
Eligibility Criteria
Inclusion
- The patient must be ≥ 18 years old at the time of signing the ICF.
- The patient must have a histologically proven adenocarcinoma of the colon or rectum.
- The patient must have liver metastases non treatable with curative intent by surgical resection or local ablation at the time of registration.
- The patient must have measurable hepatic metastases defined by RECIST version 1.1 for solid tumors.
- The patient must have received one prior chemotherapy line for metastatic disease and have developed resistance or intolerance to this treatment.
- The patient must have an ECOG performance status 0 or 1.
- The patient must have the bone marrow reserve, hepatic and renal functions
Exclusion
- Patients who are presenting evidence of ascites, cirrhosis, portal hypertension, main portal venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
- Patients who are planned to receive or concurrently receiving any non-cancer-directed investigational agent, or have received a non-cancer directed investigational agent within 3 weeks before the planned day for the first NKR-2 administration.
- Patients who are scheduled to receive concurrent growth factor (except erythropoietin), systemic steroid, other immunosuppressive therapy or cytotoxic agents (systemic or localized) other than the treatment authorized per protocol.
- Patients who underwent major surgery within 4 weeks before the planned day for the first NKR-2 administration.
- Patients who have received a live vaccine ≤ 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 :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03370198
Start Date
October 11 2017
End Date
December 15 2018
Last Update
February 28 2024
Active Locations (1)
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1
Institut Jules Bordet
Brussels, Belgium, 1000