In short
MIDRIX-LUNG-001 is an investigational cell therapy being studied in one Phase 1b trial for metastatic non-small-cell lung cancer (NSCLC). The trial, authorised in the EU, plans to enrol 64 patients and combines this therapy with anti-PD-1 treatment and chemotherapy. Its main goal is to assess the safety of preparing and giving MIDRIX-LUNG-001 alongside standard immunotherapy.
Key points
- MIDRIX-LUNG-001 is an investigational autologous dendritic cell immunotherapy for metastatic NSCLC.
- The only registered trial is a Phase 1b study with a planned enrolment of 64 patients.
- The trial combines MIDRIX-LUNG-001 with anti-PD-1 antibodies (pembrolizumab or cemiplimab) and chemotherapy.
- The primary measure is toxicity according to CTCAE v5.0 during treatment and for three months after the last vaccine dose.
- The trial is currently authorised in the EU Clinical Trials Information System.
- MIDRIX-LUNG-001 has no marketing authorisation and is not available outside clinical research.
What is MIDRIX-LUNG-001?
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. The registry name and product name are both MIDRIX-LUNG-001.
How does MIDRIX-LUNG-001 work?
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.
Which conditions is it studied for?
- Metastatic non-small-cell lung cancer (NSCLC) — lung cancer that has spread beyond the lungs. The single registered trial studies MIDRIX-LUNG-001 in this condition.
How is MIDRIX-LUNG-001 given?
MIDRIX-LUNG-001 is prepared as a solution for injection or infusion and is given by intravenous use. 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.
What do the clinical trials show?
One trial is registered for MIDRIX-LUNG-001: a Phase 1b study in metastatic NSCLC with a planned enrolment of 64 participants. 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.
What side effects are known?
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.