NCT04991948

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Celyad Oncology SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Study aims to provide insight into whether CYAD-101 administration concurrently with FOLFOX chemotherapy, followed by pembrolizumab treatment might be a treatment option for patients with unresectable metastatic colorectal cancer

Conditions

• Unresectable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CYAD-101	Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
DRUG	FOLFOX	5-FU, leucovorin and oxaliplatin
DRUG	Pembrolizumab	Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)

Timeline

• Start date: 2021-11-22
• Primary completion: 2023-08-21
• Completion: 2038-05-25
• First posted: 2021-08-05
• Last updated: 2022-03-09

Locations

5 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study