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Colon Cancer Liver MetastasisPhase 1SHRINKNCT03310008

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

A Phase 1 study testing NKR-2 cells in people with Colon Cancer Liver Metastasis, run by Celyad Oncology SA at 4 sites in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 administered concurrently with a standard chemotherapy treatment (FOLFOX) in potentially resectable liver metastases from… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer Liver Metastasis
What is being tested?
NKR-2 cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesBelgium
Study dates
7 Aug 2017to May 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi

    Charleroi, 6000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: An Open-label, Phase I Study to Assess the Safety and Clinical Activity of Multiple Doses of NKR-2, Administered Concurrently With the Neoadjuvant FOLFOX Treatment in Patients With Potentially Resectable Liver Metastases From Colorectal Cancer

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 administered concurrently with a standard chemotherapy treatment (FOLFOX) in potentially resectable liver metastases from colorectal cancer.

The trial will test three dose levels. At each dose, the patients will receive three successive administrations, two weeks apart, NKR-2 cells. The study will enroll up to 36 patients (dose escalation and expansion phases).

Being tested
NKR-2 cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NKR-2 cellsBiological

    Also called NKG2D CAR-T cells

    The intervention will consist of an infusion of NKR-2 cells administered concurrently to a standard chemotherapy every 2 weeks (14 days) for a total of 3 infusions within 4 weeks (28 days).

Study groups in NCT03310008
Study groupRoleWhat they receive
Dose level 1 (escalationExperimentalThe dose escalation arm will use a 3+3 design to determine the maximum tolerated dose.
Receives: Biological: NKR-2 cells
Dose level 2 (escalation)ExperimentalThe dose escalation arm will use a 3+3 design to determine the maximum tolerated dose.
Receives: Biological: NKR-2 cells
Dose level 3 (escalation)ExperimentalThe dose escalation arm will use a 3+3 design to determine the maximum tolerated dose.
Receives: Biological: NKR-2 cells
Recommended dose level (expansion)ExperimentalThe dose expansion arm will use the maximum tolerated dose.
Receives: Biological: NKR-2 cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of Dose Limiting Toxicities (DLT) in all patients during the study treatment until 14 days after the first NKR-2 study treatment administration

    DLT refers to any Grade 3 or higher toxicity or any Grade 2 or higher autoimmune toxicity that is experienced during treatment and within 14 days following the first NKR-2 dose, is new and at least possibly related to NKR-2 study treatment administered concurrently with chemotherapy

    Measured: up to resection (up to day 99 to day 126)

  2. The objective response rate (ORR) before resection as measured by RECIST (version 1.1)

    The objective response rate (ORR) is defined as the sum of the proportions of patients achieving CR or PR. The occurrence of ORR before resection will be reported.

    Measured: up to resection (up to day 99 to day 126)

Secondary outcomes (9)

  1. The occurrence of AEs and SAEs and any toxicity corresponding to DLT definition during the study treatment until resection visit

    The occurrence of AEs and SAEs and any toxicity corresponding to DLT definition during the study treatment until resection visit

    Measured: up to resection (up to day 99 to day 126)

  2. The occurrence of surgery complications and the wound healing status until 60 days after resection visit

    Surgery and wound healing complications experienced within the 60-day post-operative period in patients who underwent surgery will be reported as safety endpoints

    Measured: until 60 days after resection

  3. The clinical benefit rate (CBR) before resection

    The clinical benefit rate (CBR) is defined as the proportion of patients achieving CR, PR or SD. The occurrence of CBR before resection will be reported.

    Measured: up to resection (up to day 99 to day 126)

  4. The occurrence of mixed response (MR) before resection

    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)".

    Measured: up to resection (up to day 99 to day 126)

  5. The resection rate

    The presence of residual tumor following surgical resection will be assessed.

    Measured: resection (day 99 to day 126)

  6. The occurrence of pathological response at surgery

    Resected specimens. will be graded according to the two grading systems by Rubbia-Brandt et al. and Blazer et al.

    Measured: resection (day 99 to day 126)

  7. The disease-free survival (DFS) or progression-free survival (PFS)

    The disease-free survival (DFS) is defined as the time from resection of liver metastases to recurrence of tumor or death from any cause. The progression-free survival (PFS) is defined as time from study registration in the study to the disease progression or death from any cause.

    Measured: through study completion (up to month 28)

  8. 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, non-resectability, local or distant recurrence, or death from any cause.

    Measured: through study completion (up to month 28)

  9. The overall survival (OS)

    The overall survival (OS) is defined as the time from study 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.

    Measured: through study completion (up to month 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2017
  2. Study start7 Aug 2017
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Biological: NKR-2 cells The intervention will consist of an infusion of NKR-2 cells administered concurrently to a standard chemotherapy every 2 weeks (14 days) for a total of 3 infusions within 4 weeks (28 days). Other Name: NKG2D CAR-T cells
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03310008
Sponsor's protocol ID
CYAD-N2T-003
Acronym
SHRINK
Status last verified
Jun 2020
First submitted
2 Aug 2017
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NKR-2 cells in people with Colon Cancer Liver Metastasis, run by Celyad Oncology SA at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of Dose Limiting Toxicities (DLT) in all patients during the study treatment until 14 days after the first NKR-2 study treatment administration (time frame: up to resection (up to day 99 to day 126)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03310008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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