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MIDRIX-LUNG-002 is an investigational autologous dendritic cell immunotherapy. It is a cell therapy product prepared from the patient's own immune cells. The substance is classified in the CTIS product records as a structurally diverse substance of cell therapy origin, and it has no marketing authorisation — it is still being studied in clinical trials.[1] The product is supplied by Universitair Ziekenhuis Gent. The trial also includes a related product, MIDRIX-LUNG-001, as a separate investigational arm.[1]
Dendritic cells are immune cells that present pieces of foreign or abnormal proteins to other immune cells, helping to trigger an immune response against them. An autologous dendritic cell immunotherapy is made by taking dendritic cells from the patient, loading them with tumour-related material in the laboratory, and giving them back to the patient. The aim is to train the patient's immune system to recognise and attack cancer cells. The registered trial combines this approach with anti-PD-1 treatment, which blocks a signal that cancer cells use to switch off immune attacks.[1]
MIDRIX-LUNG-002 is prepared as a solution for injection or infusion and is given by intravenous use. In the trial, the dose is reported as 45,000,000 units, administered intravenously.[1] The treatment is given in combination with anti-PD-1 antibodies (pembrolizumab or cemiplimab) and, in some arms, with chemotherapy drugs such as carboplatin, cisplatin, paclitaxel or pemetrexed.[1]
One clinical trial is registered for MIDRIX-LUNG-002. It is a phase 1b, interventional study with a planned enrolment of 64 participants. The trial is currently authorised in the EU Clinical Trials Information System under the number 2025-521577-13-00.[1]
The main outcome is toxicity, assessed with the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v.5.0). Toxicity is measured during the treatment phase, from leukapheresis — the procedure that collects the patient's immune cells — until three months after the last vaccine dose.[1] The study also includes MIDRIX-LUNG-001 as a separate investigational product. Because the trial is in phase 1b, the primary focus is on safety rather than on demonstrating a survival benefit.
The registered trial is designed to measure toxicity, but the registry record does not list specific side effects that have already been observed. Toxicity will be assessed using CTCAE version 5.0 from leukapheresis until three months after the last vaccine dose.[1]
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