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 (SHRINK)

Celyad Oncology

Status and phase: Unknown; Phase 1

Conditions: Colon Cancer Liver Metastasis

Treatments: Biological: NKR-2 cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT03310008

CYAD-N2T-003

Details and patient eligibility

About

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).

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men or women ≥ 18 years old at the time of signing the ICF
2. Patients with histologically proven colorectal adenocarcinoma with potentially resectable liver metastases,
3. No previous chemotherapy for metastatic CRC,
4. The patient is due to receive first-line metastatic chemotherapy regimen with FOLFOX as a neoadjuvant
5. The patient must have an ECOG performance status 0 or 1
6. 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

Exclusion criteria

1. Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis
2. 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
3. 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
4. Patients who underwent major surgery within 4 weeks before the planned day for the first treatment
5. Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder
6. Patients who have received a live vaccine within 6 weeks prior to the planned day for the first NKR 2 administration
7. Patients with a family history of congenital or hereditary immunodeficiency
8. Patients with history of any autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

36 participants in 4 patient groups

Dose level 1 (escalation

Experimental group

Description:

The dose escalation arm will use a 3+3 design to determine the maximum tolerated dose.

Treatment:

Biological: NKR-2 cells

Dose level 2 (escalation)

Experimental group

Description:

The dose escalation arm will use a 3+3 design to determine the maximum tolerated dose.

Treatment:

Biological: NKR-2 cells

Dose level 3 (escalation)

Experimental group

Description:

The dose escalation arm will use a 3+3 design to determine the maximum tolerated dose.

Treatment:

Biological: NKR-2 cells

Recommended dose level (expansion)

Experimental group

Description:

The dose expansion arm will use the maximum tolerated dose.

Treatment:

Biological: NKR-2 cells