Clinical trial · Interventional
Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer
An Open-label Dose Escalation Phase I Study to Assess the Safety and Clinical Activity of Multiple Hepatic Transarterial Administrations of NKR-2 in Patients With Unresectable Liver Metastases From Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties in patient recruitment and clinical strategy modification based on new clinical data generated in the NKR-2 early development.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer Liver Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NKR-2 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose-level 1
- 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)
- interventionNames
- Biological: NKR-2 cells
- type
- EXPERIMENTAL
- label
- Dose-level 2
- 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)
- interventionNames
- Biological: NKR-2 cells
- type
- EXPERIMENTAL
- label
- Dose-level 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available