Study of loncastuximab tesirine and epcoritamab combination treatment for patients with relapsed or refractory diffuse large B-cell lymphoma

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What is this study about?

This study focuses on treating patients with Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma grade 3B, and High-grade B-cell Lymphoma. These are types of blood cancers that affect certain white blood cells called B-cells. The study will test a combination of two medications: loncastuximab tesirine (Zynlonta) given through an intravenous infusion into a vein, and epcoritamab given as an injection under the skin.

The purpose of this research is to determine how well patients respond to this combination treatment over a 12-month period. The medications work in different ways to target and destroy cancer cells – loncastuximab tesirine is an antibody-drug combination that delivers medication directly to cancer cells, while epcoritamab is a specialized antibody that helps the immune system recognize and fight cancer cells.

During the study, participants will receive both medications according to a specific schedule. Patients will have regular check-ups and imaging tests to monitor how their cancer responds to the treatment. The treatment period may last up to 54 weeks, depending on how well the patient responds and tolerates the medications. Throughout the study, doctors will closely monitor patients for any side effects or complications from the treatment.

1 Initial treatment phase

You will receive two medications during this study: loncastuximab tesirine through an intravenous infusion and epcoritamab as an injection under the skin.

Your treatment will be monitored for up to 12 months to assess how your body responds to the medications.

2 Disease monitoring

Regular imaging scans (PET/CT or MRI) will be performed to measure how your disease responds to treatment.

Your doctor will assess if your disease is showing complete or partial improvement, or if it remains stable or progresses.

3 Follow-up period

Your health will be monitored for up to 2 years to track long-term results.

Regular check-ups will continue to evaluate your overall survival and whether the disease returns.

Any side effects will be recorded throughout the entire study period.

4 Treatment completion

The study will track how many treatment cycles you received and their duration.

The total amount of medications you received will be documented.

Your health status will continue to be monitored for 2 months after completing the treatment.

5 Extended monitoring

Additional follow-up assessments will occur at 18 and 24 months to check your response to the treatment.

The study will continue monitoring your health status until September 2029.

Who Can Join the Study?

Must be 18 years or older
Must have confirmed B-cell lymphoma (a type of blood cancer) that has returned or not responded to previous treatment
Must be able to understand and sign an informed consent form
Must have measurable disease that can be seen on PET/CT scans (special imaging tests)
Must have general health status of ECOG 0-2 (able to perform daily activities with some limitations)
Must have failed previous treatment with either:
- First-line therapy containing specific antibodies and chemotherapy, or
- Second-line CAR-T cell therapy (a type of immune cell therapy)
Must have adequate blood test results including:
- Platelets at least 75,000/mm³
- Hemoglobin at least 8 g/dL
- White blood cells (neutrophils) at least 1,000/mm³
Must have adequate liver function tests
Must have adequate kidney function
Must have adequate heart function (ejection fraction above 45%)
Must not have received live vaccines within 28 days before screening
Must not be taking medications that weaken the immune system (except small doses of prednisone)
Must not have participated in other clinical trials within the last 30 days
For women who can become pregnant:
- Must have a negative pregnancy test
- Must use effective birth control during the study and for 12 months after
For men with partners who can become pregnant:
- Must use effective birth control during the study and for 7 months after
- Must not donate sperm during this time

Who Cannot Join the Study?

Age below 18 years or above 65 years
Previous treatment with CAR-T cell therapy (a type of treatment that modifies immune cells to fight cancer)
Active or chronic infections including:
- Hepatitis B (liver infection)
- Hepatitis C (liver infection)
- HIV (human immunodeficiency virus)
Pregnancy or breastfeeding
Major surgery within 4 weeks before starting the study
Active heart problems including:
- Heart failure
- Irregular heartbeat
- Recent heart attack
Severe kidney or liver problems
Active second cancer (other than the one being studied)
Mental conditions that could interfere with following study procedures
Participation in another clinical trial within 30 days before this study
Known allergic reactions to similar treatments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Jena KöR	Jena	Germany
University Medicine Greifswald	Greifswald	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Vivantes Netzwerk fuer Gesundheit GmbH	Berlin	Germany
Muehlenkreiskliniken AöR	Minden	Germany
Ortenau Klinikum	Offenburg	Germany
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts	Mutlangen	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinenhilfe gGmbH	Stuttgart	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Philipps-Universitaet Marburg	Marburg	Germany
Saarland University Hospital	Homburg	Germany
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
St. Barbara-Klinik Hamm GmbH	Hamm	Germany
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH	Paderborn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Ujccukiseelqikuchigpy Eoaba Aod	Essen	Germany
Ukgxeemusokwwjeywgxgz Acyayvop	Augsburg	Germany
Udpqfvnmcpjsbbjfgdzrn Dlsnmtjfcsu Abo	Duesseldorf	Germany
Udewoklpbwrwcupcnxgqp Mwacvsnu Aac	Munster	Germany
Gmazfe Uuteigadju Fwsgioxze	Frankfurt	Germany
Kdhewijr dkq Uffrsdaivftl Motbpzpa Aus	Munich	Germany
Kmkpp Sxa Pceahv Gyeh	Dortmund	Germany
Mprszxqiudrtaolnovegykuwec Hshmyqdaxfnlvsyx	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	30.09.2025

Trial locations

Investigated drugs:

Loncastuximab Tesirine is a medication specifically designed to treat certain types of blood cancer. It’s an antibody-drug that targets and attacks specific cancer cells in patients with lymphoma. This medication works by delivering a toxic substance directly to cancer cells that have a particular protein on their surface, helping to destroy these harmful cells while minimizing damage to healthy cells.

Epcoritamab is a bispecific antibody treatment that helps the body’s immune system fight against lymphoma. It works by connecting immune cells (T-cells) to cancer cells, enabling the immune system to better recognize and destroy the cancer cells. This medication is designed to treat patients whose lymphoma has returned or hasn’t responded to previous treatments.

Investigated diseases:

Diffuse Large B-cell Lymphoma (DLBCL) – A fast-growing cancer that develops in the lymphatic system from B-cells, a type of white blood cell. The disease affects lymph nodes and can spread to other parts of the body. It causes lymph nodes to become enlarged, and patients may experience fever, night sweats, and weight loss. DLBCL is the most common type of non-Hodgkin lymphoma in adults.

Follicular Lymphoma Grade 3B (FL Grade 3B) – A specific subtype of blood cancer that develops from B-lymphocytes in the lymphatic system. The term “follicular” refers to the circular pattern that the lymphoma cells form in the lymph nodes. Grade 3B indicates a more aggressive form of follicular lymphoma, where the cancer cells appear larger and divide more quickly than in lower grades.

High-Grade B-cell Lymphoma (HGBL) – An aggressive form of lymphoma that develops from abnormal B-lymphocytes. The term “high-grade” refers to the fact that the cancer cells look very different from normal cells and multiply quickly. This lymphoma can affect multiple lymph nodes and organs simultaneously. The disease typically progresses rapidly if left untreated.

Trial ID:

2023-509861-19-01

Protocol code:

WWU23_0006

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of loncastuximab tesirine and epcoritamab combination treatment for patients with relapsed or refractory diffuse large B-cell lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?