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

NCT ID: NCT03310008

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-07
• Study Completion Date: 2021-05-31

Brief 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 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).

Conditions

Colon Cancer Liver Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose level 1 (escalation

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

Group Type: EXPERIMENTAL

NKR-2 cells

Intervention Type: BIOLOGICAL

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).

Dose level 2 (escalation)

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

Group Type: EXPERIMENTAL

NKR-2 cells

Intervention Type: BIOLOGICAL

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).

Dose level 3 (escalation)

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

Group Type: EXPERIMENTAL

NKR-2 cells

Intervention Type: BIOLOGICAL

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).

Recommended dose level (expansion)

The dose expansion arm will use the maximum tolerated dose.

Group Type: EXPERIMENTAL

NKR-2 cells

Intervention Type: BIOLOGICAL

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).

Interventions

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).

Intervention Type: BIOLOGICAL

Other Intervention Names

NKG2D CAR-T cells

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celyad Oncology SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric Lehmann, MD

Role: PRINCIPAL_INVESTIGATOR

Celyad Oncology SA

Locations

Institut Jules Bordet

Brussels, , Belgium

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Grand Hôpital de Charleroi

Charleroi, , Belgium

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

CYAD-N2T-003

Identifier Type: -

Identifier Source: org_study_id