Breast cancer:

Am I eligible for the LION-1 study?

In the LION-1 study, researchers are investigating the efficacy and tolerability of a new variant of CAR-T cell therapy. Patients with breast cancer can also participate. However, they must meet various requirements.

When can breast cancer patients participate in LION-1?

The participant must be 18 years of age or older.
The diagnosis of triple-negative breast cancer is confirmed by laboratory tests (histological).
The tumour cells carry ROR1 on their surface.
The patient has no health restrictions or requires only minimal support. The study physicians use the ECOG status for classification.
Exception: The limitation is permanent and was already present before the cancer diagnosis, for example due to a spinal cord injury.
Tumour tissue and/or any metastasis are located outside the bones and are positioned in such a way that doctors can reliably measure their size using Computed tomography, CT.
Patients must have already undergone the therapies that are standard and promising for their disease situation.
The liver is not too severely damaged.
The participant understands the benefits and risks of the study and agrees to participate.
The patient is willing and able to attend the necessary appointments and examinations as part of the study observation.
Men must commit to either abstaining from sex or using a condom for at least one year after receiving the study drug. This also applies to men who have had a vasectomy.
Women who can become pregnant must agree to use highly effective contraception during the study period to prevent pregnancy. A pregnancy test will also be carried out as part of the preliminary examinations, which must be negative to participate in the study.
Women are not allowed to breastfeed during the study and for up to 1 year after receiving the study drug.

Which contraceptives are highly effective?

The following are considered highly effective contraceptives:

Hormone preparations containing either a combination of oestrogen and progestogen or progestogen alone, which prevent ovulation.
Intrauterine device (IUD) and hormonal IUDs.
Tubal ligation.
Vasectomy (surgical sterilisation) performed on the male partner.
Sexual abstinence.

When can breast cancer patients not participate in LION-1?

If one of the above criteria does not apply.
The cancer has metastasised to the central nervous system. Exception: The metastasis has been treated, and any corticosteroids will be discontinued at least 1 week before infusion of the study drug.
Another cancer has been present in the last 2 years. Exception: Successfully treated and locally confined tumours such as skin cancer or prostate cancer.
There are indications of HIV infection.
There is an infection with syphilis or hepatitis B or C. Exceptions are possible in certain cases and can be discussed with the study doctors.
There is an acute infection (e.g. with COVID-19) or another serious physical or mental illness.
An ultrasound examination of the heart shows that the pumping capacity of the left ventricle is too low or there are other heart problems.
Kidney function is too severely impaired.
There is a coagulation disorder. Exceptions are possible in certain cases and can be discussed with the study doctors.
You are currently being treated with drugs that suppress the immune system (such as cortisone).
There is abuse of alcohol, drugs or medication.
The person concerned is employed by the study sponsor.
The person concerned is employed by or related to the study researchers.

This study description was prepared by authors from the Cancer Information Service, under the direction of Dr. S. Weg-Remers, based on the study documentation.

Back to the study description of LION-1