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
Celyad Oncology SA
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.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. Histologically proven metastatic adenocarcinoma of the colon or rectum. 1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum. 2. Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status 3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). 4. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease which must include FOLFOX chemotherapy 5. The patient is due to receive FOLFOX chemother…
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 ClinicJacksonville, Florida
- Moffit Cancer CenterTampa, Florida
- UZ AntwerpenEdegem
- UZ GentGhent
- UZ LeuvenLeuven