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MIDRIX-LUNG-001 is an investigational substance classified as a structurally diverse cell therapy. It is an autologous dendritic cell immunotherapy, meaning it is prepared from the patient's own immune cells. The product is supplied by Universitair Ziekenhuis Gent and has no marketing authorisation in the product records, so it is available only within clinical research.[1] The registry name and product name are both MIDRIX-LUNG-001.
The trial summary describes the intervention as an autologous dendritic cell immunotherapy used in combination with anti-programmed death-1 (anti-PD-1) treatment. Dendritic cells are immune cells that help the body recognise and attack cancer cells. In this approach, the patient's own dendritic cells are collected, prepared, and given back to help stimulate an immune response against the tumour. The registered data do not describe a specific molecular target for MIDRIX-LUNG-001.[1]
MIDRIX-LUNG-001 is prepared as a solution for injection or infusion and is given by intravenous use.[1] In the trial, the dose is recorded as 45,000,000 units, administered intravenously. The trial also uses a related product, MIDRIX-LUNG-002, at the same dose. The exact number of doses and the treatment schedule are not described in the registry record.
One trial is registered for MIDRIX-LUNG-001: a Phase 1b study in metastatic NSCLC with a planned enrolment of 64 participants.[1] The trial is authorised in the EU Clinical Trials Information System. It is interventional and combines MIDRIX-LUNG-001 with anti-PD-1 therapy. The anti-PD-1 drugs listed in the trial are pembrolizumab (KEYTRUDA) and cemiplimab (LIBTAYO). Chemotherapy agents in the trial include carboplatin, cisplatin, paclitaxel, and pemetrexed. The primary outcome is toxicity, defined by the Common Toxicity Criteria for Adverse Events version 5.0 (CTCAE v5.0). Toxicity is assessed from leukapheresis until three months after the last vaccine dose. The trial record does not report efficacy results or enrolment status beyond the planned number of participants.
The registry record for this trial does not provide a list of side effects for MIDRIX-LUNG-001. The primary outcome of the trial is to measure toxicity, which means the study is designed to find out what side effects occur when the therapy is combined with anti-PD-1 treatment and chemotherapy.[1]
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