RecruitingPhase 1NCT03692429

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


Sponsor

Celyad Oncology SA

Enrollment

49 participants

Start Date

Nov 28, 2018

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of immune cell therapy called CYAD-101 — made from donor T cells that are modified to attack colon and rectal cancer — combined with standard chemotherapy (FOLFOX or FOLFIRI), in patients with advanced colorectal cancer that has spread and is no longer responding to standard treatments. **You may be eligible if...** - You have been diagnosed with metastatic (spread) colorectal cancer that cannot be surgically removed - Your cancer has progressed after at least one prior chemotherapy regimen for metastatic disease - Your cancer can be measured on scans - You are well enough to carry out daily activities (ECOG 0 or 1) - Your bone marrow, liver, kidney, lung, and heart function are adequate **You may NOT be eligible if...** - Your cancer has spread to the brain or spinal cord - You have had a prior bone marrow transplant, CAR T-cell therapy, or other gene-modified T-cell therapy - You received certain other investigational drugs recently - You received certain growth factor medications within 7 days of planned treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Tampa, Florida, United States

Institut Jules Bordet

Brussels, Belgium

UZ Antwerpen

Edegem, Belgium

UZ Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03692429


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