AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC

This study is looking into a new treatment called DJI136. It's a special type of 'CAR-T therapy' where a patient's own immune cells are changed in a lab to better fight cancer. This study is for adults with a type of advanced lung cancer called extensive-stage small cell lung cancer. It's an early-stage study (Phase I/II) to learn about the safety of DJI136 and what side effects it might cause. Researchers are also watching to see if the treatment helps shrink the cancer. Before getting DJI136, patients will receive some other medicines like bendamustine and fludarabine. Another medicine, tocilizumab, might be given if needed to manage side effects. The study aims to find the right dose and understand how well it works.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

Start

27 May 2026

Extensive stage small cell lung cancer

What is this study about?

This research study is investigating a new treatment called DJI136 for adults who have extensive-stage small cell lung cancer. This means the cancer has spread beyond the lung where it started. DJI136 is a cutting-edge type of therapy called CAR-T cell therapy. In CAR-T therapy, a patient's own immune cells (T-cells) are collected and specially modified in a lab. These modified cells are then put back into the patient, where they are designed to find and attack cancer cells more effectively. This treatment specifically targets something called DLL3, which is often found on small cell lung cancer cells.

The study is in its early phases (Phase I and Phase II), which means it's one of the first times this treatment is being given to people. The main goals are to understand how safe DJI136 is, what side effects it might have, and if it causes any serious reactions. Researchers will also be looking closely at how patients respond to the treatment, such as whether their tumours shrink or stop growing. This helps them decide if the treatment is promising enough to test in larger studies.

Before receiving the main treatment, DJI136, participants will be given other medications like bendamustine and fludarabine. These are often used to prepare the body for CAR-T therapy. Another medication, tocilizumab, might be used if necessary to help manage certain side effects that can sometimes occur with CAR-T therapies. The information gathered from this study is crucial for determining the future development of DJI136 as a potential new option for treating this aggressive form of lung cancer.

Key takeaways

This study is testing a new CAR-T cell treatment (DJI136) for advanced small cell lung cancer.
It's an early-stage study focused on safety and potential effectiveness.
The treatment involves preparing your own immune cells to fight cancer.
You will receive other medicines before and potentially during the main treatment.
Participation involves regular hospital visits, tests, and monitoring.
There are potential benefits and risks; your doctor will explain them fully.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and both men and women are welcome to take part. The study is specifically for individuals diagnosed with extensive-stage small cell lung cancer.

There will be other detailed health requirements that your doctor will check. These might include things like your overall health, how well your organs are working, and if you have certain other medical conditions. These checks are important to make sure the study is safe for you.

Not everyone with this type of cancer will be able to join. Your doctor or study team will carefully review all your medical information to see if you meet all the necessary criteria to participate in this specific research.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with extensive-stage small cell lung cancer?
Are you able to travel to the study site for appointments?
Are you comfortable with receiving an experimental treatment?
Do you have a good general health status, as determined by a doctor?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you'll first undergo a series of tests to confirm you meet all the health requirements. If eligible, your immune cells will be collected. You will then receive certain medications, like bendamustine and fludarabine, to prepare your body for the main treatment, DJI136, which will be given as an infusion. During this time, and afterwards, you will have regular clinic visits, blood tests, heart checks (ECGs), and other examinations to monitor your health, look for side effects, and see how the treatment is working. If you experience certain side effects, you might also receive tocilizumab. The study will involve ongoing check-ups for a period of time to track your progress and any changes in your health. The total duration of your participation, including follow-up, will be explained by the study team, but typically these types of studies involve months of active treatment and follow-up.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as access to a new, experimental treatment that isn't yet widely available, and it could help doctors learn more about your illness. However, there are also potential risks, as this is an early-stage treatment and side effects might be unknown or serious. The medications given, including DJI136, bendamustine, fludarabine, and tocilizumab, all carry their own risks and potential side effects which your doctor will explain. There's also no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Spain
—
France

Common questions

What is 'CAR-T therapy'?

CAR-T therapy is a newer type of cancer treatment where your own immune cells are specially trained in a lab to find and destroy cancer cells.

What does 'extensive-stage small cell lung cancer' mean?

This means your small cell lung cancer has spread beyond the lung where it started, to other parts of your body.

Will I have to stay in the hospital?

It's common to need hospital stays or frequent visits, especially after receiving CAR-T cell therapy, for close monitoring of your health.

What are the main things the doctors are looking for in this study?

They are mainly watching for any side effects and seeing how safe the treatment is. They also want to see if the treatment helps shrink or control the cancer.

What is a 'Phase I/II' study?

This means it's an early study to see if the new treatment is safe and to find the right dose, while also getting an early idea of how effective it might be.