In short
DJI136 is an investigational cell therapy being studied in people with extensive-stage small cell lung cancer. It has no marketing authorisation and is given by intravenous infusion. One authorised Phase 1/2 trial is currently testing its safety, tolerability, and early anti-tumour activity in 66 participants.
Key points
- DJI136 is an investigational cell therapy with no marketing authorisation.
- It is being studied in extensive-stage small cell lung cancer.
- The single authorised trial is Phase 1/2 and plans to enrol 66 participants.
- The trial measures safety, dose-limiting toxicity, and overall response rate.
- DJI136 is given by intravenous infusion as a dispersion for infusion.
- The trial is run by Novartis Pharma AG.
What is DJI136?
DJI136 is an investigational substance classified as a cell therapy. It is a structurally diverse substance, which means it is not a simple chemical molecule but a more complex biological product. The substance is being developed by Novartis Pharma AG and has no marketing authorisation in the product records, meaning it is not yet approved as a medicine.
In the EU Clinical Trials Information System, DJI136 is recorded under the therapeutic area of neoplasms, which covers cancers. The only product name listed for this substance is DJI136 itself, and it appears as the test substance in one trial.
How does DJI136 work?
The available registry data do not describe a specific molecular target or mechanism of action for DJI136. As a cell therapy, it is expected to act through living cells rather than through a chemical interaction with a single target, but no further details are provided in the trial record.
Which conditions is it used or studied for?
- Extensive-stage small cell lung cancer — a form of lung cancer that has spread widely within the chest or to other parts of the body. This is the only condition in which DJI136 is currently being studied.
How is DJI136 given?
DJI136 is prepared as a dispersion for infusion and is given by intravenous infusion, meaning it is delivered directly into a vein over a period of time. The trial record lists DJI136 as an intravenous infusion.
What do the clinical trials show?
There is one authorised clinical trial of DJI136, registered in the EU Clinical Trials Information System with the number 2025-523276-23-00. It is a Phase 1/2 interventional study that plans to enrol 66 participants with extensive-stage small cell lung cancer.
The trial has two main goals. In all study parts, it aims to characterise the safety and tolerability of DJI136 and to identify the recommended dose or doses for future studies. In Phase II Group A, it also aims to evaluate the preliminary anti-tumour activity of DJI136.
The primary outcome measures include the incidence and severity of adverse events, serious adverse events, changes in laboratory values, vital signs, and electrocardiograms, as well as the incidence and nature of dose-limiting toxicities. In Phase II Group A, the overall response rate is measured according to RECIST v1.1, a standard way of assessing whether tumours shrink or disappear.
In addition to DJI136, the trial includes several other drugs: bendamustine hydrochloride, cyclophosphamide, fludarabine phosphate, and tocilizumab, all given intravenously. These are listed as interventions in the trial record and are likely used as part of the treatment regimen or to manage side effects, but the record does not specify their exact role.
The trial is currently authorised, meaning it has received regulatory approval to proceed but may not yet be recruiting participants.
What side effects are known?
The trial record does not report specific side effects of DJI136. The study is designed to measure the incidence and severity of adverse events and serious adverse events, which means side effects will be collected during the trial. No side effect data are available yet.