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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
NKR-2 cells will be administered (hepatic transarterial administration) every 2 weeks (14 days) for a total of 3 administrations within 4 weeks (28 days)
Institut Jules Bordet
Brussels, Belgium
The occurrence of DLTs until 14 days after the last NKR-2 study treatment administration (Visit Day 43)
A DLT is defined as any Grade 3 or higher toxicity and any Grade 2 or higher autoimmune toxicity
Time frame: From study treatment start (Day 1) till 14 days after the last NKR-2 study treatment administration (Day 43)
The occurrence of AEs and SAEs during the study treatment until 30 days after the last study treatment administration (Visit Day 57)
AEs and SAEs collection
Time frame: From study treatment start (Day 1) till 30 days after the last study treatment administration (Day 57)
The occurrence and duration of objective clinical response (complete response (CR), partial response (PR))
Complete response (CR), partial response (PR)
Time frame: through study completion (up to month 24)
The occurrence and duration of clinical benefit (complete response (CR), partial response (PR) and stable disease (SD))
Complete response (CR), partial response (PR) and stable disease (SD)
Time frame: through study completion (up to month 24)
The occurrence and duration of mixed response (MR)
The different types of MR are defined according to the following criteria: at least 30% decrease in the longest diameter (or shortest diameter for nodal lesions) occurring in at least one target lesion recorded and measured at baseline. Such response occurring in otherwise SD or PD status of the sum of diameters of target lesions and without the appearance of one or more new lesions will be classified as "MR (SD)", which corresponds to a SD with target lesion regression or "MR (PD)", which corresponds to PD with target lesion regression and, the appearance of new lesion(s) in otherwise PR status of the sum of diameters of target lesions will be classified as "MR (PR)", which corresponds to a PR with new lesion.
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Time frame: through study completion (up to month 24)
The resection rate at Visits Day 57 and Month 3
Assessment of R0, R1 and R2 resections
Time frame: At visits Day 57 and Month 3
The progression-free survival (PFS)
The progression-free survival (PFS) is defined from registration in the study to the disease progression or death from any cause
Time frame: through study completion (up to month 24)
The event-free survival (EFS)
The event-free survival (EFS) is defined as the time from registration in the study to any of the following events: progression, local or distant recurrence, or death from any cause
Time frame: through study completion (up to month 24)
The overall survival (OS).
The overall survival (OS) is defined as the time from registration in the study to death. If death does not occur before the patient's last study visit, then the survival will be censored at the date when patient is known to be alive
Time frame: through study completion (up to month 24)