alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells

Part of paid clinical trials in Tampa, Florida.

Sponsor
Celyad Oncology SA
Study ID
NCT03692429
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
  • FOLFIRI — DRUG
    5-FU, leucovorin and irinotecan

Study Details

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

Key Dates

Start date
Nov 28, 2018
Status verified
Nov 2020
Primary completion
Nov 28, 2021
Completion
Feb 17, 2036

Study Design

Enrollment
49 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CYAD-101 with FOLFOX
    Infusion after standard FOLFOX chemotherapy
  • Experimental: CYAD-101 with FOLFIRI
    Infusion after standard FOLFIRI chemotherapy

Primary Outcome Measure

Occurence of Dose Limiting Toxicities [ Time Frame: Up to 82 days post first CYAD-101 Infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffit Cancer CenterTampaFlorida33612
Kim Dae Won, MD
Kim Dae Won (PRINCIPAL_INVESTIGATOR)

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