A FIH, Phase I/IIa, Trial Assessing Feasibility of Administrations of TIL-based Immunotherapy in Patients With Metastatic CRC and PC
Trial Parameters
Brief Summary
This is a First-In-Human trial investigating a novel expansion protocol of an ATIMP (CC-38), composed of autologous TIL.
Eligibility Criteria
Inclusion Criteria: * 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. * Patient has histological or cytological confirmation of: * colorectal cancer, which is stage IV (any T / any N / M1), not amenable to curative surgery, OR * prostate cancer, which is stage III locally advanced, not amenable to curative surgery (T3-4 / N0 / M0 or any T / N1 / M0), or stage IV metastatic (any T / any N / M1) * Patient has received all lines of therapy that * are considered SOC for the patient's indication according to applicable European/national professional society medical guidelines and local medical practice at time of enrollment * are available via the national health insurance system and the patient is considered eligible f