Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Celyad Oncology SA
- Study ID
- NCT04991948
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Unresectable Metastatic Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CYAD-101 — DRUGAllogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
- FOLFOX — DRUG5-FU, leucovorin and oxaliplatin
- Pembrolizumab — DRUGHumanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
Study Details
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.
Key Dates
- Start date
- Nov 22, 2021
- Status verified
- Feb 2022
- Primary completion
- Aug 21, 2023
- Completion
- May 25, 2038
Study Design
- Enrollment
- 34 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumab
Primary Outcome Measure
The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period' [ Time Frame: Up to 73 days post first study treatment administration ]
Central Contacts
- Celyad Oncology Medical Monitor, MD, PhD+3210394100
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | Jeremy Jones |
| Moffit Cancer Center | Tampa | Florida | 33612 | Kim Dae Won, MD Kim Dae Won (PRINCIPAL_INVESTIGATOR) |
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