NCT03692429

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Celyad Oncology SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Unresectable Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CYAD-101	Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
DRUG	FOLFOX	5-FU, leucovorin and oxaliplatin
DRUG	FOLFIRI	5-FU, leucovorin and irinotecan

Timeline

• Start date: 2018-11-28
• Primary completion: 2021-11-28
• Completion: 2036-02-17
• First posted: 2018-10-02
• Last updated: 2020-11-20

Locations

4 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study