Not yet recruitingPHASE2INTERVENTIONAL

Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

This phase 2 study is exploring a new combination treatment for aggressive types of B-cell lymphoma, including Diffuse Large B-cell Lymphoma (DLBCL) and certain high-grade lymphomas, that have either returned or not responded well to earlier treatments. The trial aims to see how safe and effective the medicines Loncastuximab Tesirine and Epcoritamab are when given together. We're looking for adults aged 18 or older. This includes people who haven’t had a specific cell therapy called CAR-T, or those who had CAR-T but it didn't work. The study will carefully check for side effects and how well the treatment helps control the lymphoma.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Universität Münster

Enrolment target

120

Start

15 Oct 2025

Estimated completion

15 Jan 2030

Aggressive Diffuse Large B-cell Lymphoma High-grade B-cell Lymphoma (HGBL)Follicular Lymphoma (FL) Grade 3B

What is this study about?

You're reading this because you, or someone you care about, is dealing with a challenging type of blood cancer called lymphoma. Specifically, this study focuses on aggressive forms of B-cell lymphoma, like Diffuse Large B-cell Lymphoma (DLBCL), which are types of cancer that start in immune cells called B-cells. For some people, these lymphomas can be difficult to treat, returning after initial treatments or not responding as expected.

This study is trying out a new approach by combining two different medicines: Loncastuximab Tesirine and Epcoritamab. Both of these medicines work in unique ways to target and fight cancer cells. By using them together, doctors hope to find a more effective way to treat these aggressive lymphomas, especially for people who haven't had success with previous treatments. This is a 'Phase 2' study, which means we're looking closely at how safe the combination is and how well it works in a larger group of patients compared to earlier studies.

We're particularly interested in helping people whose lymphoma has come back (relapsed) or hasn't improved with treatment (refractory). This includes people who haven't yet received a specific advanced cell therapy called CAR-T cell therapy, as well as those who have had CAR-T therapy but found it wasn't successful. The goal is to see if this new combination can offer a new and better treatment option.

Key takeaways

This study is testing a new combination of two drugs for aggressive B-cell lymphoma.
It's for people whose lymphoma has returned or hasn't responded to previous treatments.
You must be 18 years or older to participate.
The study aims to find out how safe and effective this new combination therapy is.
Participation involves regular hospital visits and monitoring.
You can discuss with your doctor if this study might be right for you.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. The main requirement is that you have an aggressive B-cell lymphoma that has either come back after treatment or didn't respond to previous treatments. This includes types like Diffuse Large B-cell Lymphoma (DLBCL), certain high-grade B-cell lymphomas, and Follicular Lymphoma Grade 3B.

We would need to review your medical records, including a recent biopsy, to confirm the type of lymphoma and that it expresses a specific marker called CD20. You would also need to be considered healthy enough by the study doctor to start new treatment. We are looking for people who need to start treatment now, based on their symptoms or how much the disease has progressed.

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?
Have you been diagnosed with an aggressive B-cell lymphoma (like DLBCL, certain high-grade types, or Follicular Lymphoma Grade 3B)?
Has your lymphoma come back after treatment, or did it not respond well to previous treatments?
Are you currently in need of starting a new treatment for your lymphoma?
Were you told your previous treatments didn't work (refractory disease), or your lymphoma returned quickly (early relapse)?
Have you had a recent biopsy that confirms your lymphoma and its characteristics?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll receive the new combination of Loncastuximab Tesirine and Epcoritamab. You'll have regular hospital visits for treatments, check-ups, and to monitor how you're doing. These visits will involve blood tests, physical exams, and possibly scans to see how the lymphoma is responding and to check for any side effects. The exact schedule will vary, but expect frequent visits initially, becoming less frequent over time. The study will enrol 120 patients in total, and safety will be carefully checked after the first 20 patients begin treatment, with effectiveness reviewed after 50 patients are recruited. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to a new experimental treatment combination that could help control your lymphoma, especially if previous treatments haven't worked. However, there are also potential risks involved. These medicines can have side effects, which the study team will monitor very closely. They will explain all known and potential side effects to you. It's incredibly important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Universitätsklinikum Münster, Medizinische Klinik A
Verified postcode
Münster, Germany

Common questions

What is an 'aggressive' B-cell lymphoma?

Aggressive B-cell lymphomas are types of cancer that tend to grow and spread more quickly than other lymphomas, meaning they often need prompt and strong treatment.

What does 'relapsed/refractory' mean?

'Relapsed' means your lymphoma has come back after a period of improvement from previous treatment. 'Refractory' means your lymphoma didn't respond well to earlier treatments, or it started growing again very quickly after treatment.

What are Loncastuximab Tesirine and Epcoritamab?

These are two different medicines that target cancer cells in specific ways. Scientists hope that using them together will be more effective in fighting your lymphoma.

Is this a new type of treatment?

Yes, this study is looking at these two medicines together as a treatment combination, which is new for patients with this type of lymphoma. This type of research helps doctors find better ways to treat cancer.

Will I get 'CAR-T cell therapy' in this study?

No, this study is for individuals who either haven't had CAR-T cell therapy before, or who have, but it wasn't successful. This study is testing a different combination of medicines.

How to find out more

Georg Lenz, Prof.

lenzsekr@ukmuenster.de +492518347587 Official trial record

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