An Open-label, Phase I Study to Assess the Safety of Multiple Doses of CYAD-101, Administered After Standard FOLFOX or FOLFIRI Chemotherapy in Patients With Unresectable Metastatic Colorectal Cancer
Celyad Oncology SA
Summary
The purpose of the alloSHRINK study is to assess the safety, cell kinetics and clinical activity of CYAD-101 in patients with unresectable metastatic colorectal cancer administered after standard chemotherapy
Description
This Study aims to determine and confirm the recommended dose of the allogeneic CYAD-101 cells after standard FOLFOX or FOLFIRI chemotherapy in patients with unresectable metastatic colorectal cancer
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically proven metastatic adenocarcinoma of the colon or rectum. 1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum. 2. Recurrent/progressing disease after at least one line of systemic therapy for metastatic disease. 3. Unequivocal and measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). 4. FOLFOX segment: Neurotoxicity less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 from previous chemotherapy. 5. FOLFIRI segment: Documented progressive disease (P…
Interventions
- DrugCYAD-101
Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
- DrugFOLFOX
5-FU, leucovorin and oxaliplatin
- DrugFOLFIRI
5-FU, leucovorin and irinotecan
Locations (4)
- Moffit Cancer CenterTampa, Florida
- Institut Jules BordetBrussels
- UZ AntwerpenEdegem
- UZ LeuvenLeuven