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,
Single group
CC-38
DrugCC-38 drug product is an autologous ATIMP composed of in vitro expanded tumor-infiltrating T-lymphocytes.
Pembrolizumab
DrugA concomitant IMP is pembrolizumab
Cyclophosphamid
DrugCyclophosphamid is used as a AxMP
Interleukin-2
DrugInterleukin-2 is used as a AxMP.
Uromitexan
DrugUromitexan is used as a AxMP.
Evaluation of safety, tolerability, and feasibility of repeated administrations of the novel ATIMP, CC-38.
Incidence of treatment-emerged adverse events (TEAE) and the occurrence of severity grade 3 or higher adverse events according to NCI CTCAE v. 5.0; proportion of patient receiving at least two CC-38 administrations without TEAEs preventing CC-38 administrations
Evaluation of efficacy of repeated administrations of the novel ATIMP CC-38 in patients
Measurable objective response rate: Proportion of patients with complete \[CR\] or partial response \[PR\] as best response to treatment within the first 6 months after start of CC-38 administration (RECIST 1.1/iRECIST), or death from any cause, whichever comes first. Progression-free survival: time from start of treatment to time of disease progression (RECIST 1.1/ iRECIST), or death from any cause, whichever comes first. Time to tumor progression: time from start of treatment to disease progression (RECIST 1.1/iRECIST) Overall survival (OS): time from start of treatment to time of death from any cause. For prostate cancer cohort: Patient individual changes in prostate-specific antigen levels from baseline until 6 months after start of treatment. For colorectal cancer cohort: Patient individual changes in carcinoembryonic antigen and cancer antigen 19-9 levels from baseline until 6 months after start of treatment.
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CuraCell TX AB
Lead sponsor
Zellwerk GmbH
Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborator
Krebsforschung Rhein-Main e.V.
Collaborator
