RecruitingPHASE1INTERVENTIONAL

A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies

This is an early-stage clinical trial (Phase I) looking into a new treatment called MDC-CAR-BCMA001. This treatment uses your own specially modified immune cells to fight certain advanced blood cancers. The main goal is to check how safe this new therapy is and to find the highest dose that can be given without causing too many side effects. It's for adults with specific types of blood cancers, such as diffuse large B-cell lymphoma (DLBCL) or multiple myeloma, where previous treatments haven't worked or the cancer has returned. By understanding the safety first, we can take steps towards potentially developing new ways to treat these challenging cancers.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Technische Universität Dresden

Enrolment target

Start

15 Feb 2024

Estimated completion

01 Jun 2027

Neoplasms Relapsed Diffuse Large B-cell Lymphoma (DLBCL)Refractory Diffuse Large B-cell Lymphoma (DLBCL)Multiple Myeloma, Refractory Multiple Myeloma in Relapse

What is this study about?

This study is a Phase I clinical trial, which means it's one of the first times this new treatment is being tested in people. The main purpose is to see if a new therapy, called MDC-CAR-BCMA001, is safe and can be tolerated by people with certain blood cancers. These are cancers that have either returned after treatment or haven't responded well to other available therapies.

The treatment involves taking some of your own immune cells, called T-cells, and changing them in a laboratory. These modified T-cells are then given back to you. They are designed to recognise and attack specific cancer cells. This approach, known as CAR T-cell therapy, is a type of immunotherapy that uses your body's own defence system to fight cancer. The researchers are trying to find the best dose to give that is both effective and doesn't cause too many unwanted side effects.

Finding new ways to treat blood cancers like diffuse large B-cell lymphoma (DLBCL) and multiple myeloma is very important, especially for those whose cancer has been difficult to treat with current options. While this is an early study primarily focused on safety, the information gathered will help determine if this treatment has the potential to become a future treatment option for these conditions.

Key takeaways

This is an early-stage study (Phase I) checking the safety of a new cell therapy.
The treatment, MDC-CAR-BCMA001, uses your own specially modified immune cells.
It's for specific types of blood cancers, like some lymphomas and multiple myeloma, that are advanced.
The main goal is to find the safest dose of the treatment.
Participation involves close medical monitoring and regular hospital visits.
There are potential benefits and risks, which will be fully explained.

Who may be eligible?

This study is looking for adult men and women, aged 18 or older, who are able and willing to follow the study plan. You would need to be well enough to take part, as assessed by a doctor, and have certain blood cancers that have either come back or not responded to previous treatments. Your current overall health should be reasonably good, meaning you can carry out most daily activities without too much difficulty.

Specifically, if you have Multiple Myeloma, your cancer must have returned or not responded after at least two different types of treatment. If you have Diffuse Large B-cell Lymphoma (DLBCL), your cancer must have returned or not responded after standard treatments, or after a stem cell transplant, or after certain other cell therapies. Before joining, your doctor would confirm that other standard treatments are not suitable for you at this time.

There are also specific blood test results and other health checks you would need to meet to ensure it's safe for you to participate in this early-stage treatment study. These detailed criteria are important to protect your health during the trial.

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.

Are you 18 years old or older?
Do you have a diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) or Multiple Myeloma?
Has your cancer come back or not responded to previous treatments?
Are you generally well enough to manage daily activities without major difficulty?
Are you able and willing to follow the special schedule of doctor's appointments and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have regular visits to the hospital for check-ups, blood tests, and scans to monitor your health and how you are responding to the treatment. This includes a process where your T-cells are collected, then sent to a lab to be modified into the MDC-CAR-BCMA001 therapy. You will then receive the modified cells back as an infusion. The study involves a detailed follow-up schedule to carefully watch for any side effects and see how the treatment is working. The total duration of your participation, including follow-up, will be explained in detail by the study team, but typically involves close monitoring for several months and then less frequent check-ups over a longer period.

Potential risks and benefits

Potential benefits of joining this study include receiving a new, experimental treatment that might help if your cancer hasn't responded to other therapies. While the main goal is to find a safe dose, there's a chance the treatment could help control your cancer. However, as with any new treatment, there are potential risks, including side effects from the cell collection process, the conditioning treatment before receiving the CAR T-cells, and the CAR T-cells themselves. These side effects can range from mild to serious, and the study team will monitor you closely for them. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Technische Universität Dresden, NCT/UCC, Early Clinical Trial Unit
Verified postcode
Dresden, Germany· Recruiting

Common questions

What is a Phase I trial?

A Phase I trial is the first stage of testing a new medicine or treatment in humans. It focuses mainly on safety and finding the right dose, rather than how well it works.

What is CAR T-cell therapy?

CAR T-cell therapy uses your own immune cells, called T-cells, which are specially changed in a lab to find and destroy cancer cells.

What does 'relapsed and refractory' mean?

It means the cancer has either returned after previous treatment (relapsed) or didn't respond to previous treatments at all (refractory).

Will I get this new treatment if I join?

If you meet all the study requirements, you would receive the MDC-CAR-BCMA001 treatment, as this is a dose-finding study.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any point, and it won't affect your future medical care.

How to find out more

Martin Wermke, Prof.

carlotta@ukdd.de +49 351 458 13408 Official trial record

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