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 — DRUG
    Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
  • FOLFOX — DRUG
    5-FU, leucovorin and oxaliplatin
  • Pembrolizumab — DRUG
    Humanized 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

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Jeremy Jones
Moffit Cancer CenterTampaFlorida33612
Kim Dae Won, MD
Kim Dae Won (PRINCIPAL_INVESTIGATOR)

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