RecruitingPhase 1NCT04991948

Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer

An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer


Sponsor

Celyad Oncology SA

Enrollment

34 participants

Start Date

Nov 22, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the CYAD-101-002 study is to assess the safety and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether pembrolizumab (an immunotherapy drug) given after an experimental cell therapy called CYAD-101 (with FOLFOX chemotherapy) can help patients with metastatic colorectal cancer that has not responded to earlier treatments. **You may be eligible if...** - You are 18 or older with confirmed metastatic colorectal cancer (colon or rectal) - Your cancer is not the MSI-high type (a specific genetic characteristic) - Your cancer has progressed after at least one prior treatment including FOLFOX - You have measurable disease and are in good general health (ECOG 0–1) - You have adequate organ function - You are willing to have a tumor biopsy at the start of the study **You may NOT be eligible if...** - You have had prior anti-PD-1/PD-L1 immunotherapy - You have had another investigational treatment in the last 4 weeks - You have current or prior pneumonitis requiring steroids - You have had major surgery or radiotherapy within 4 weeks - You have an uncontrolled serious illness or infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYAD-101

Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells

DRUGFOLFOX

5-FU, leucovorin and oxaliplatin

DRUGPembrolizumab

Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)


Locations(5)

Mayo Clinic

Jacksonville, Florida, United States

Moffit Cancer Center

Tampa, Florida, United States

UZ Antwerpen

Edegem, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

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NCT04991948


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