AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase I, first-in-human clinical trial to evaluate safety of infusion of STAb-T19 cells: genetically modified T lymphocytes secreting αCD19xαCD3 bispecific antibodies for malignant B-cell neoplasms

This is a very early clinical trial, often called a Phase 1 study, for adults with specific types of blood cancer. The main goal is to check the safety of a new treatment named "STAb-T19 cells." These are special immune cells, called T-cells, which have been changed in a lab to help them find and kill cancer cells. They do this by making a special protein that acts like a bridge, connecting the cancer cells to the T-cells so the T-cells can attack. This is the first time these STAb-T19 cells will be given to people, so researchers are carefully watching for any side effects and how the body reacts to them. This study is an important first step in understanding if this new therapy could eventually help patients.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Fundacion Para La Investigacion Biomédica Del Hospital Universitario 12 De Octubre

Enrolment target

Start

22 Apr 2026

Malignant B-cell neoplasms

What is this study about?

You might have heard about cancer treatments that use your body's own immune system to fight off cancer. This study is exploring a new type of treatment like that, using something called STAb-T19 cells. Imagine your body has special soldier cells, called T-cells, that normally protect you from infections. In this treatment, scientists take some of a patient's own T-cells, make a clever change to them in the lab, and then put them back into the body. These changed T-cells then become super-soldiers, designed to specifically find and attack cancer cells.

The special change made to these T-cells allows them to produce a unique protein. Think of this protein as a tiny, clever grappling hook. It has two arms: one arm grabs onto the cancer cells, and the other arm holds onto the T-cell. This creates a strong link that helps the T-cell spot the cancer and then destroy it. The specific type of cancer this study is focusing on involves "B-cells," which are another type of immune cell that can sometimes become cancerous. This treatment aims to target these cancerous B-cells.

Because this is the very first time these STAb-T19 cells will be given to people, it's called a Phase 1 study. The most important thing for researchers at this stage is to carefully check if the treatment is safe and what doses can be given without causing serious problems. They will also be looking to see if there are any signs that the treatment is working. This is a crucial early step in developing new medicines, and studies like this help us understand if a new treatment has the potential to help people in the future.

Key takeaways

This is a new, early-stage study for certain blood cancers.
The main goal is to check the safety of a new cell therapy called STAb-T19 cells.
This treatment uses your own specially modified immune cells to fight cancer.
It's the first time these cells will be given to people.
Participation involves close monitoring in the hospital and follow-up appointments.
You can stop participating at any time.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older. Both men and women can participate. To be considered, you must have a type of cancer that affects your B-cells.

There will be other important health checks to make sure this study is right for you. For example, doctors will need to ensure your kidneys, liver, and heart are working well enough to safely take part. They will also check if you have certain infections or other conditions that might make this treatment unsafe for you.

Everyone joining the study will have detailed medical tests to confirm they meet all the specific requirements. Your doctor will be able to tell you if your particular health situation matches what the researchers are looking for.

Quick self-check

Are you 18 years old or older?
Do you have a type of cancer that involves B-cells?
Are you generally well enough to undergo cancer treatment?
Are you able to attend all required hospital visits and follow-up appointments?

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

What does participation involve?

If you decide to take part, you'll first have a series of screening tests to make sure you're eligible. This might include blood tests, scans, and other checks. You'll then receive the STAb-T19 cells through a drip, similar to a blood transfusion.

After getting the treatment, you will need to stay in the hospital for a period of time so the doctors and nurses can closely monitor you. They will regularly check your blood, vital signs, and overall health to look for any side effects or how your body is reacting to the new cells. You will also have follow-up appointments for many months, possibly up to a few years, after the treatment. These appointments will help researchers understand the long-term safety and effects of the treatment. The total duration of active treatment and follow-up can vary by individual.

Potential risks and benefits

Taking part in this study could potentially offer a new way to treat your cancer, especially if other treatments haven't worked or aren't suitable. However, because this is a first-time-in-humans study, there might be unknown side effects or risks that doctors are not yet aware of. You might experience common side effects like fever or tiredness, or more serious reactions. You will be closely monitored to manage any side effects. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What are B-cell neoplasms?

These are types of cancer that start in immune cells called B-cells, which are found in your blood and lymphatic system. Examples include some forms of lymphoma and leukaemia.

What does 'Phase I' mean?

Phase I is the earliest stage of human testing for a new drug. The main goal is to find out if the treatment is safe and what dose can be given, rather than how well it works.

What are STAb-T19 cells?

These are a type of your own immune cells (T-cells) that have been specially altered in the lab to help them find and kill cancer cells more effectively.

Will this treatment replace my current cancer treatment?

This is a research study. Your study doctor will discuss how this treatment fits with your overall cancer care plan. It may be offered after other treatments have been tried.

Will I definitely get better if I join this study?

As this is a very early study, we don't know for sure if the treatment will make you better or cure your cancer. The main aim is to check its safety. Any positive effect on cancer is a secondary goal at this stage.