This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.
Patient (female or male) has signed informed consent according to ICH/GCP and national/local regulations prior to any trial-specific procedure.
Patient is 18 years or older at the time of signing the informed consent form.
Patient must live in an area where a hospital for care can be reached within a maximum of 50 km.
colorectal cancer, which is stage IV (any T / any N / M1), not amenable to curative surgery, OR
Congestive heart failure NYHA class III or IV,
myocardial infarction or coronary artery bypass graft within 6 months prior to enrollment,
history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration,
history of severe non-ischemic cardiomyopathy,
CuraCell TX AB
Lead sponsor
Zellwerk GmbH
Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborator
Krebsforschung Rhein-Main e.V.
Collaborator