DALY clinical trial in Europe

DALY 2-EU clinical trial

The DALY 2-EU clinical trial examines if our CAR-T cell investigational medicinal product, zamtocabtagene autoleucel, has a better efficacy than the current chemotherapeutic standard of care used to treat patients with DLBCL.

Are there any requirements to participate in the DALY 2-EU clinical trial?

Age ≥ 18 years
Male or female
Patients diagnosed with DLBCL or associated subtype.
Patients who received one previous therapy to treat their disease.
Patients who had a relapse of the disease within 2 years from start of the first line therapy.
Not eligible for high dose chemotherapy and stem cell transplantation.
Consenting to participate in this clinical trial.

If you volunteer for this trial, you will be assessed to confirm your eligibility. After these tests you will be randomly assigned to receive the control treatment or our investigational medicinal product. Clinical trials testing two different treatments in comparison to each other are called randomized clinical trials.
There are more criteria for you to participate. For further information, please contact your doctor or the doctor at the CAR-T cell center.

What happens during the DALY 2-EU clinical trial?

If you are eligible and agree to volunteer in the DALY 2-EU 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. You will also be asked 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 doctor if volunteering for the DALY 2-EU clinical trial is right for you.

How long does the DALY 2-EU clinical trial take and do I need to stay in hospital?

If you are assigned to receive our CAR-T cell treatment, you will be hospitalized for up to one month which includes your preparation for therapy, the infusion of the CAR-T cell product and the first two weeks of follow-up after infusion. If you are assigned to receive the control treatment, the treating physician will determine your treatment plan according to their discretion. Your health condition will be closely monitored for 2 years after your hospitalization for CAR-T cell treatment or control treatment.

What is the purpose of having a randomized clinical trial?

We are comparing a chemotherapy combination to our CAR-T cell product to evaluate which treatment provides a superior outcome in DLBCL patients.

What if my cancer progresses after receiving the standard of care therapy?

If you've been randomized to receive the standard of care treatment and you relapse or your cancer progresses during the first year of the study, you may be eligible for crossover treatment with the investigational medicinal product.

Can I leave the DALY 2-EU clinical trial?

All participants have the right to withdraw from participation in this study at any time, for any reasons and without prejudice to future medical care to which a participant is entitled.

Will I know if I receive CAR-T cells?

Yes, you will be informed by the medical staff if you receive CAR-T cells immediately after you have been assigned to this treatment.

Is the DALY 2-EU clinical trial approved?

The conduct of the DALY 2-EU clinical trial has been accepted by regulatory authorities in several European countries.

How can I participate in the DALY 2-EU clinical trial?

Please contact your doctor for further information about the DALY 2-EU clinical trial.

DALY 2-EU European clinical trial locations

We are regularly updating the clinical trial locations for Europe. To find your nearest location please visit ClinicalTrials.gov (NCT04844866).