DALY II-USA clinical trial

The DALY II-USA clinical trial examines the efficacy of the investigational medicinal product zamtocabtagene autoleucel in patients suffering from DLBCL or B cell CNS lymphoma. To participate in this trial, you must have previously received 2 or more different treatment regimens.

Cell blue 1
Cell blue 2
Are there any requirements to participate in the DALY II-USA clinical trial?
  • Age ≥ 18 years
  • Male or female
  • Patients diagnosed with DLBCL or associated subtype, or with B cell primary or secondary CNS lymphoma.
  • Patients who received at least two previous therapies to treat their disease for DLBCL without CNS involvement or at least one prior therapy line for patients with CNS lymphoma.
  • Consenting to participate in this clinical trial.

If you participate in this trial, you will be assessed to confirm your eligibility. 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 II-USA clinical trial?
If you agree to participate in the DALY II-USA 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 for a longer period of time.
You should discuss with your doctor if participating in the DALY II-USA clinical trial is right for you.
What are the benefits to participating in DALY II-USA compared to receiving an approved product?
Some benefits of your participation in the DALY II-USA clinical trial may include:
  • Access to a novel therapy that is not publicly available
  • Regular appointments with medical professionals
  • Playing an important role in the development of a therapy.
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.
How long does the DALY II-USA clinical trial take and do I need to stay in hospital?
You may be hospitalized for 2 weeks or 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. Patients may be treated in the outpatient setting, with only 24 hours post-treatment hospitalization. After your hospitalization your health condition will be closely monitored for two years.
Is the DALY II-USA clinical trial approved?
We were given the permission by the FDA to perform the DALY II-USA clinical trial. In addition, the local Institutional Review Board (an ethics committee for the hospital) have approved the hospitals to participate in the DALY II-USA clinical trial.
How can I participate in the DALY II-USA clinical trial?
Please contact your doctor for further information about the DALY II-USA clinical trial.

DALY II-USA clinical trial locations

We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.

map
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Pin
Arizona
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
California
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Connecticut
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Florida
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Illinois
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Kansas
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Maryland
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Massachusetts
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Michigan
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Minnesota
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
New York
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
North Carolina
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Ohio
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Oregon
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Pennsylvania
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Texas
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.
Wisconsin
We are regularly including new clinical trial sites in the USA. Please visit NCT04792489 to find your closest clinical trial site.

Glossary

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.

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.