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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
5-FU, leucovorin and oxaliplatin
Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
Mayo Clinic
Jacksonville, Florida, United States
NOT_YET_RECRUITINGMoffit Cancer Center
Tampa, Florida, United States
NOT_YET_RECRUITINGUZ Antwerpen
Edegem, Belgium
RECRUITINGThe Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
The occurrence of DLT during the 'DLT reporting period' is defined as the period from study enrollment on D1 (Visit 1) up to 3 weeks after first pembrolizumab treatment on D73 (Visit 14).
Time frame: Up to 73 days post first study treatment administration
The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15])
The objective response rate (ORR) at the tumor assessment on Day 94 \[Visit 15\]), 6 weeks after the first pembrolizumab treatment administration.
Time frame: Up to 94 days post first study treatment administration
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UZ Gent
Ghent, Belgium
NOT_YET_RECRUITINGUZ Leuven
Leuven, Belgium
RECRUITING