Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer (LINK)

Celyad Oncology

Status and phase: Terminated; Phase 1

Conditions: Colon Cancer Liver Metastasis

Treatments: Biological: NKR-2 cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT03370198

CYAD-N2T-004

Details and patient eligibility

About

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 dose levels (dose escalation). At each dose, the patients will receive three successive hepatic transarterial administrations, two weeks apart, of NKR-2 cells. The study will enroll up to 18 patients.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 3 patient groups

Dose-level 1

Experimental group

Description:

The dose-level 1 arm will use a 3+3 design. NKR-2 cells will be administered every 2 weeks (14 days) for a total of 3 administrations (hepatic transarterial administrations) within 4 weeks (28 days)

Treatment:

Biological: NKR-2 cells

Dose-level 2

Experimental group

Description:

The dose-level 2 arm will use a 3+3 design. NKR-2 cells will be administered every 2 weeks (14 days) for a total of 3 administrations (hepatic transarterial administrations) within 4 weeks (28 days)

Treatment:

Biological: NKR-2 cells

Dose-level 3

Experimental group

Description:

The dose-level 3 arm will use a 3+3 design. NKR-2 cells will be administered every 2 weeks (14 days) for a total of 3 administrations (hepatic transarterial administrations) within 4 weeks (28 days)

Treatment:

Biological: NKR-2 cells