DALY 2-EU clinical trial information

Learn more about DALY 2-EU

DALY II-USA clinical trial information

Learn more about DALY II-USA

DALY: clinical trials for patients with DLBCL

DALY trials in Europe and the USA

What are the DALY clinical trials?

DALY are two clinical trials sponsored by Miltenyi Biomedicine to investigate our new investigational medicinal product, zamtocabtagene autoleucel, a CAR-T cell product for patients suffering from diffuse large B cell lymphoma (DLBCL).

Two DALY clinical trials are recruiting patients, DALY 2-EU and DALY II-USA. In DALY 2-EU, our investigational medicinal product will be compared to another treatment whilst DALY II-USA will evaluate zamtocabtagene autoleucel without comparison to another treatment. The conduct of the DALY clinical trials has been accepted by regulatory authorities in several European countries and the USA.

About the DALY clinical trials for DLBCL

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Has this drug been tested with other patients before?
The investigational medicinal product of the DALY clinical trials is zamtocabtagene autoleucel. To date, most of the approved CAR-T cell therapies are intended to treat patients suffering from blood cancer such as leukemia or lymphoma.
The DALY clinical trials are based on a previous clinical study with the same investigational medicinal product in patients suffering from aggressive B cell lymphoma treated at three study sites in Germany.
What happens during this clinical trial?
If you qualify and agree to participate in a DALY clinical trial, you will be asked to complete a series of assessments to determine the effect of the treatment on your disease. The assessments will start before, during, and after you receive your treatment. We will ask you to participate in a long-term clinical study to allow Miltenyi Biomedicine to observe you and your disease for a longer period of time.
You should discuss with your healthcare professional if participating in the DALY clinical trial is right for you.

The different steps of the CAR-T cell treatment

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    Leukapheresis collection:
    The required volume of blood is collected and shipped to the manufacturing facility where the investigational product is produced.

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    Preparation for the CAR-T cell therapy:
    The patient receives chemotherapy (lymphodepletion), at the CAR-T cell center to reduce the number of blood cells.

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    Infusion of CAR-T cells:
    After manufacturing, the CAR-T cells are shipped back to the hospital and the patient receives a single infusion containing their own CAR-T cells.

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What are the risks when participating in this clinical trial?
DALY clinical trials are examining the safety and efficacy outcomes after the infusion of the investigational medicinal product. You may experience side effects from your treatment. Please speak to your doctor to learn more about the potential side effects.
While there are risks and benefits to any clinical trial or treatment you should discuss this topic with your doctor and determine if this clinical trial is right for you.
Can l leave the trial if I do not want to participate anymore?
All participants have the right to withdraw from participation in the DALY clinical trial at any time, without disclosing any reasons and without prejudice to future medical care to which a participant is entitled.
Can I receive the COVID-19 vaccine before I enroll?
Since the COVID-19 vaccination strategy is different in each region, we would like to ask you to discuss this question, or any other concerns related to COVID-19 with your doctor or the doctor at the CAR-T cell center. Miltenyi Biomedicine is unable to offer any COVID-19 vaccine as part of the DALY trial.
Do I have to pay for my participation in the DALY trial?
The study medication, related procedures and parts of the travel expenses will be covered by Miltenyi Biomedicine. Please discuss these details with your doctor at the CAR-T cell center.

DALY trial local information

DALY 2-EU clinical trial information

Learn more about DALY 2-EU

DALY II-USA clinical trial information

Learn more about DALY II-USA

About CAR-T cell therapy

Understand how personalized CAR-T cell therapy works to fight cancer.

Learn more about CAR-T cell therapy


Chimeric antigen receptor (CAR) T cells

T cells are part of the immune system that protects against diseases. CAR-T cells are altered T cells to fight cancer.

CAR-T cell center

CAR-T cell center is a unit of a hospital specialized in CAR-T cell treatment.

Diffuse large B cell lymphoma (DLBCL)

DLBCL is an aggressive cancer of B cells. It is the most common form of non-Hodgkin lymphoma.

Investigational medicinal product

An investigational medicinal product is a pharmaceutical form of an active substance being tested in a clinical trial.


Leukapheresis is a procedure where specific blood cells are collected from the patient’s blood for CAR-T cell manufacturing.


Lymphodepletion is a treatment using chemotherapeutic drugs to prepare the patient for a CAR-T cell therapy.