In short
CC-38 is an investigational cell therapy made from a patient's own tumor-infiltrating lymphocytes (TILs). It is being studied in a first-in-human Phase 1/2 trial for people with locally advanced or metastatic prostate cancer or metastatic colorectal cancer whose disease has progressed. The trial plans to enroll 12 participants and is currently authorised. It is given by intravenous infusion and has no marketing authorisation.
Key points
- CC-38 is an autologous tumor-infiltrating lymphocyte (TIL) cell therapy made from a patient's own tumour cells.
- The only registered trial is Phase 1/2 and is currently authorised.
- The trial plans to enrol 12 participants with metastatic colorectal or prostate cancer.
- Participants must have progressive disease to be eligible.
- The main goal is to measure safety, tolerability, and feasibility of repeated CC-38 infusions.
- CC-38 is given as a suspension for intravenous infusion and has no marketing authorisation.
What is CC-38?
CC-38 is an investigational cell therapy classified as a structurally diverse substance of cell therapy origin. It is a type of tumor-infiltrating lymphocyte (TIL) immunotherapy, meaning it is made from immune cells taken from a patient's own tumour. The substance has no marketing authorisation in the product records, so it is not yet an approved medicine. The authorisation holder is CuraCell Holding AB.
How does CC-38 work?
Tumor-infiltrating lymphocytes are immune cells that have naturally moved into a tumour. In TIL therapy, these cells are collected from the patient's tumour tissue, expanded in a laboratory, and then given back to the patient by infusion. The aim is to strengthen the body's own immune response against the cancer. The trial is testing whether repeated administrations of these cells are safe and feasible.
Which conditions is CC-38 studied for?
- Metastatic colorectal cancer — bowel cancer that has spread to other parts of the body.
- Locally advanced or metastatic prostate cancer — prostate cancer that has grown beyond the prostate or spread to other organs.
Participants must have progressive disease, meaning their cancer is getting worse despite previous treatment.
How is CC-38 given?
CC-38 is prepared as a suspension for intravenous infusion and is given directly into a vein. In the registered trial, it is administered together with other medicines: pembrolizumab (Keytruda), aldesleukin (Proleukin), cyclophosphamide, and mesna (Uromitexan). These are given as part of the treatment regimen.
What do the clinical trials show?
There is one registered clinical trial for CC-38. It is a first-in-human, Phase 1/2a, open-label trial, meaning it is the first time the therapy is being tested in people and both researchers and participants know what treatment is being given.
The trial is currently authorised and plans to enrol 12 participants. The primary outcomes are the incidence of treatment-emergent adverse events (side effects that appear during treatment) and the proportion of patients who can receive at least two TIL administrations without side effects that would prevent further treatment.
What side effects are known?
The trial is designed to measure side effects as its main goal, but no specific side effect data for CC-38 has been reported yet. The study records the occurrence and severity of adverse events according to standard criteria (NCI CTCAE v5.0).