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

CELL-BASED IMMUNOTHERAPY FOR TREATMENT OF TRIPLE NEGATIVE BREAST CANCER STAGES II AND III

Doctors are running a new study to see if a special type of cell therapy can help people with a specific kind of breast cancer called triple-negative breast cancer. This type of cancer is often harder to treat because it doesn't respond to many common medicines. The study is for people whose cancer is in stages II or III. This is an early trial, meaning it's one of the first times this treatment is being given to humans. The main goals are to check if the treatment is safe for patients and to see if it shows any signs of working against the cancer. It's a key step in developing new ways to fight this challenging disease.

At a glance

Status

Authorised

Phase

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

Sponsor

Celica d.o.o.

Enrolment target

Start

31 Mar 2026

TRIPLE NEGATIVE BREAST CANCER

What is this study about?

This study is about exploring a new way to treat breast cancer, specifically a type known as triple-negative breast cancer. This kind of breast cancer is different because it lacks certain features that doctors usually target with medications, making it more challenging to treat with standard hormone therapies or targeted drugs. The aim of this research is to see if a treatment that uses special cells from a patient's own body (sometimes called 'cell-based immunotherapy') can help fight this cancer.

The study is in its early stages, known as Phase I and Phase II. This means it's one of the first times this particular treatment is being given to people. The main goals are to make sure the treatment is safe for patients and to start understanding if it can help slow down or shrink the cancer. They are looking for participants with stage II or stage III triple-negative breast cancer.

Developing new treatments for triple-negative breast cancer is very important because current options can be limited. If this new cell treatment proves to be safe and shows promising results in this study, it could open doors for more advanced research and potentially offer a new treatment choice for patients in the future.

Key takeaways

This study is for triple-negative breast cancer in stages II or III.
It's testing a new 'cell-based' treatment option.
It's an early-stage trial focusing on safety and initial effectiveness.
Open to adults aged 18 and over, both men and women.
Participation involves receiving the new treatment and close medical monitoring.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. There is no upper age limit, so people of many different ages can take part.

The study is specifically for individuals diagnosed with triple-negative breast cancer. Your cancer would need to be in either stage II or stage III. Triple-negative means your breast cancer cells don't have certain receptors that are usually targeted by hormone therapy or other specific drugs.

Both men and women can be considered for this study, as breast cancer can affect anyone. Other medical details, which will be discussed with your doctor, will also determine if the study is a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with triple-negative breast cancer?
Is your breast cancer in stage II or stage III?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new cell-based treatment. This will involve several visits to the hospital or clinic for treatments and check-ups. You'll have regular tests, which might include blood tests, scans, and possibly biopsies, to monitor how you're responding to the treatment and to keep an eye on your overall health. The specific number of visits and the duration of the treatment and follow-up will be carefully explained to you by the study team. You will be closely monitored by doctors and nurses throughout your participation.

Potential risks and benefits

As with any new treatment, there are potential benefits and risks to consider. A potential benefit is that this new treatment might help control your cancer, especially if other treatments haven't been as effective. However, because this is an early-stage study, the full benefits are not yet known. Potential risks could include side effects from the treatment, which the study team will discuss and monitor closely. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovenia

Common questions

What does 'triple-negative breast cancer' mean?

It means the cancer cells don't have three specific features (receptors) that doctors usually target with hormone therapy or other specific drugs, making it different to treat.

What is 'cell-based immunotherapy'?

It's a treatment that uses special cells, often from your own body, to help your immune system fight the cancer.

What does 'Phase I and Phase II' mean?

These are early stages of testing a new treatment in people. Phase I tests safety, and Phase II looks at safety and if the treatment works.

Will I get this new treatment if I join the study?

Yes, if you meet the study requirements and choose to participate, you will receive the new cell-based immunotherapy treatment being tested.

Can men join this study?

Yes, the study is open to both men and women with triple-negative breast cancer.