DALY 2-EU clinical trial information
Learn more about DALY 2-EUDALY II-USA clinical trial information
Learn more about DALY II-USADALY: 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
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.
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
Leukapheresis collection:
The required volume of blood is collected and shipped to the manufacturing facility where the investigational product is produced.
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.
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.
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.
DALY trial local information
DALY 2-EU clinical trial information
Learn more about DALY 2-EUDALY II-USA clinical trial information
Learn more about DALY II-USAAbout CAR-T cell therapy
Understand how personalized CAR-T cell therapy works to fight cancer.
Learn more about CAR-T cell therapyGlossary
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 is a unit of a hospital specialized in CAR-T cell treatment.
DLBCL is an aggressive cancer of B cells. It is the most common form of non-Hodgkin lymphoma.
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.
B cell central nervous system lymphoma (CNS) lymphoma
Both primary and secondary B cell CNS lymphomas are rare subsets of B cell non-Hodgkin’s lymphoma.
Investigational medicinal product
Investigational medicinal product is a pharmaceutical form of an active substance being tested in a clinical trial.
Diffuse large B cell lymphoma (DLBCL)
DLBCL is an aggressive cancer of B cells. It is the most common form of non-Hodgkin lymphoma.
Leukapheresis
Leukapheresis is a procedure where specific blood cells are collected from the patient’s blood for CAR-T cell manufacturing.
Lymphodepletion
Lymphodepletion is a treatment using chemotherapeutic drugs to prepare the patient for a CAR-T cell therapy.
CAR-T cell center
CAR-T cell center is a unit of a hospital specialized in CAR-T cell treatment.
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.
Neurological toxicity
Neurological toxicity is the presence of at least one neurological symptom appearing after CAR-T cell infusion. Their clinical spectrum is very heterogeneous.
Cytokine Release Syndrome
Cytokine Release Syndrome is a collection of symptoms that can develop as a side effect of CAR-T- cell therapy. The syndrome occurs when immune cells are activated and release large amounts of cytokines (inflammatory components) into the body.