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

Celyad Oncology SA36 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colon Cancer Liver Metastasis

Interventions

NKR-2 cells

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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