In short
Autologous T cells genetically modified to express a chimeric antigen receptor directed against CD30 and CEA is an investigational cell therapy being studied for colorectal adenocarcinoma that has spread to the liver. One authorised phase 1/2 trial is currently listed in the EU Clinical Trials Information System, planning to enrol 18 participants. The trial is assessing safety, dose finding, and feasibility of the therapy.
Key points
- Phase 1/2 trial in colorectal adenocarcinoma with liver metastases
- Planned enrolment of 18 participants
- Trial status is authorised in the EU Clinical Trials Information System
- Main goals are safety, dose finding, and feasibility
- Therapy is given by intravenous use
- Primary outcomes include adverse events and dose-limiting toxicities
What is this substance?
Autologous T cells genetically modified to express a chimeric antigen receptor directed against CD30 and CEA is an investigational cell therapy. It is made from a patient's own T cells, which are collected, genetically modified in a laboratory, and then given back to the patient. The modification enables the T cells to recognise and attack cancer cells that carry two specific proteins: CD30 and CEA (carcinoembryonic antigen). In the trial record, the therapy is referred to as CD30/CEA CART.
How does it work?
The therapy works by directing a patient's own immune cells against cancer cells. The chimeric antigen receptor (CAR) is a synthetic protein added to the T cells. It is designed to recognise two targets found on certain cancer cells: CD30 and CEA. When the modified T cells encounter cancer cells carrying these targets, they are intended to bind to them and trigger an immune response against the tumour. The trial data do not provide further details on the mechanism beyond this targeting approach.
Which conditions is it studied for?
- Colorectal adenocarcinoma — a type of bowel cancer. The trial focuses specifically on patients whose cancer is CEA-positive and has spread to the liver (liver metastases).
How is it given?
The therapy is given by intravenous use, meaning it is administered directly into a vein. It is a cell therapy prepared individually for each patient from their own T cells. The trial record lists the pharmaceutical form as a drug for intravenous use.
What do the clinical trials show?
One clinical trial is listed in the EU Clinical Trials Information System for this therapy. The trial is a phase 1/2a study, which combines early testing of safety and dose finding with initial assessment of feasibility. It is currently authorised, meaning it has received regulatory approval to proceed.
The trial plans to enrol 18 participants. It is an interventional study, meaning participants receive the investigational therapy. The primary goals are to assess the safety and tolerability of CD30/CEA CART, to identify the maximum tolerated dose and/or recommended phase 2 dose, and to evaluate feasibility by measuring the percentage of participants who receive the planned dose.
The primary outcomes measured in the trial include the incidence and severity of adverse events and adverse events of special interest, grouped by MedDRA system organ class and preferred terms according to CTCAE version 6.0. The trial also measures the occurrence of dose-limiting toxicities during the dose-limiting toxicity evaluation period, and the percentage of participants who received the planned dose of CD30/CEA CART.
What side effects are known?
No side effect data are available from the sources provided. The trial is designed to measure the incidence and severity of adverse events as its primary outcome, but results have not been reported in the registry record.