RecruitingPHASE2INTERVENTIONAL

DALY II USA/ MB-CART2019.1 for DLBCL

This study, called DALY II USA, is a Phase 2 trial looking into a new type of treatment called zamtocabtagene autoleucel (MB-CART2019.1). It's for people with certain types of lymphoma, like Diffuse Large B-cell Lymphoma (DLBCL), High Grade B-cell Lymphoma, or Mantle Cell Lymphoma, whose disease has come back or hasn't responded to previous treatments. Researchers want to see how effective this new treatment is, how safe it is, and how it moves through the body. The treatment involves taking your own immune cells, changing them in a lab, and then putting them back into your body to fight the cancer. This study is for people who have already tried other treatments, typically at least two lines of therapy for most types of lymphoma included.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Miltenyi Biomedicine GmbH

Enrolment target

248

Start

25 May 2021

Estimated completion

31 Dec 2028

Refractory Diffuse Large B Cell Lymphoma (DLBCL)Relapsed Diffuse Large B Cell Lymphoma High Grade B-cell Lymphoma (HGBCL)Primary Mediastinal B-cell Lymphoma (PMBCL)Transformed Lymphoma Central Nervous System Lymphoma Mantle Cell Lymphoma (MCL)Richter Transformation

What is this study about?

This study, known as DALY II USA, is looking at a new treatment called zamtocabtagene autoleucel (you might hear it called MB-CART2019.1) for certain types of lymphoma. Lymphoma is a type of cancer that starts in infection-fighting cells of the immune system called lymphocytes. The study is specifically focusing on people whose lymphoma has either come back after treatment or hasn't responded to their current treatments.

This new treatment is a type of CAR T-cell therapy. It works by taking some of your own immune cells, called T-cells, from your blood. These cells are then sent to a lab where they are specially trained to recognise and fight cancer cells in your body. Once they're ready, these modified cells are given back to you through a drip, like a blood transfusion.

The main goal of this study is to see how well this new treatment works in shrinking or controlling the lymphoma, and importantly, to understand if it's safe and what side effects it might have. Researchers are gathering information over time to help understand this potential new therapy better.

Key takeaways

This study is for certain types of lymphoma that have come back or not responded to existing treatments.
It tests a new cell therapy called zamtocabtagene autoleucel (MB-CART2019.1).
The treatment involves taking and re-engineering your own immune cells to fight cancer.
The main goals are to see how well the treatment works and if it is safe.
Participants will undergo initial cell collection, chemotherapy, cell infusion, and then long-term monitoring.

Who may be eligible?

To join this study, you would generally need to have a specific type of B-cell lymphoma, such as Diffuse Large B-cell Lymphoma (DLBCL), High Grade B-cell Lymphoma, Primary Mediastinal B-cell Lymphoma, or others like Mantle Cell Lymphoma or Richter's Transformation. Your lymphoma must have either returned after previous treatments or not responded to those treatments.

For most types of lymphoma in the study, you would need to have already received at least two different lines of treatment. This might include treatments like rituximab and anthracycline-based chemotherapy. If you have central nervous system (CNS) lymphoma, your eligibility criteria might be slightly different, but still involve having received at least one prior treatment for your condition.

The doctors will also check your overall health and medical history to make sure that taking part in the study would be safe for you. They will review all your information carefully to see if you fit all the requirements for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have Diffuse Large B-cell Lymphoma or another specified B-cell lymphoma?
Has my lymphoma either come back or not responded to my previous treatments?
Have I already received at least two different courses of treatment for my lymphoma (or at least one for CNS lymphoma)?
Am I at least 18 years old?
Am I generally well enough to go through this type of treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step is a screening process to confirm you meet all the requirements. If you do, you'll have a procedure called 'leukapheresis'. This is where some of your blood is taken, and special machines separate out your immune cells (T-cells), which are then sent to a lab to be specially prepared. After your cells are collected, you'll receive some chemotherapy medication (like cyclophosphamide and fludarabine, or bendamustine) for a few days to prepare your body for the new cells.

Once your specially prepared cells are ready, they will be given back to you through a drip into a vein. After this, you'll have regular check-ups and assessments for up to two years to see how you're doing, how the treatment is working, and to keep an eye on any side effects. There will also be a separate, longer-term follow-up to monitor your health even further.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment that isn't widely available yet, which might help if standard treatments haven't worked for you. However, there are also potential risks, as this is an investigational treatment, and side effects can occur, some of which might be serious. The research team will explain all known and potential risks in detail. It's important to remember that joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (25)

Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
Mayo Clinic
Verified postcode
Phoenix, United States· Recruiting
UC San Diego Health
Verified postcode
La Jolla, United States· Recruiting
Stanford University
Verified postcode
Stanford, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Recruiting
Baptist Health Miami Cancer Institute
Verified postcode
Miami, United States· Recruiting
Winship Cancer Institute of Emory University
Verified postcode
Atlanta, United States· Recruiting
Georgia Cancer Center at Augusta University
Verified postcode
Augusta, United States· Recruiting
Robert H Lurie Cancer Center
Verified postcode
Chicago, United States· Recruiting
University of Kansas Cancer Center
Verified postcode
Westwood, United States· Recruiting
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
Verified postcode
Baltimore, United States· Recruiting
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting

Common questions

What is Diffuse Large B-cell Lymphoma (DLBCL)?

DLBCL is a common type of fast-growing cancer that starts in white blood cells called lymphocytes, affecting the lymph nodes and sometimes other parts of the body.

What is 'relapsed' or 'refractory' lymphoma?

Relapsed means your lymphoma has come back after treatment. Refractory means your lymphoma didn't respond or stopped responding to treatment.

What is zamtocabtagene autoleucel (MB-CART2019.1)?

It's a type of CAR T-cell therapy, where your own immune cells are taken, specially trained in a lab to fight cancer, and then put back into your body.

What is a Phase 2 study?

A Phase 2 study focuses on how effective a new treatment is for a specific condition and continues to assess its safety after it's been tested in a smaller group of people (Phase 1).

How long will I need to be followed up?

You'll be regularly followed for up to two years to check on the treatment's effects and your general health, with even longer-term follow-up planned under a separate programme.

How to find out more

Bryan Dumont

clinicaltrials@miltenyi.com 617-218-0044 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.