Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymp… (NCT07197307) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Combining Loncastuximab Tesirine and Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Germany120 participantsStarted 2025-10-15
Plain-language summary
This is a phase II study designed to evaluate the toxicity and efficacy of the combination of loncastuximab tesirine and epcoritamab in patients with relapsed/refractory aggressive B-cell lymphoma. Chimeric antigen receptor (CAR)-T cell naive patients who have failed first-line therapy and patients who have received CAR-T cells as second-line therapy and experienced CAR-T failure will be eligible for inclusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects with histologically confirmed relapsed/refractory DLBCL based on pathology report (WHO 2022 criteria)
. DLBCL (de novo or transformed)
. High-grade B-cell lymphoma with MYC and BCL2 rearrangements
. High-grade B-cell lymphoma, not otherwise specified (NOS)
. Follicular lymphoma grade 3B
. Subject must be 18 years or older.
. Subject must be eligible to receive and in need of treatment initiation based on symptoms and/or disease burden, as assessed by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best overall response rate (BORR)
Timeframe: 12 months after the start of study therapy
. Eastern Cooperative Oncology Group Performance (ECOG) status 0-2.
Exclusion criteria
. Any prior lymphoma-directed treatment, except for first-line anti-CD20-/anthracycline-containing chemoimmunotherapy or second line CAR-T cell therapy. Particularly, patients previously treated with loncastuximab tesirine and any CD3xCD20 bispecific antibody therapy are not eligible.
. Patients with late relapse (\>12 months) after first-line immunochemotherapy considered HDCT/ASCT eligible as assessed by the local investigator.
. Known central nervous system (CNS) involvement.
. Diagnosed or treated for any malignancy other than r/r DLBCL, HGBL or FL grade 3B within the last 3 years, except for adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, non-invasive basal cell or squamous cell skin carcinoma, adequately treated carcinoma in situ without evidence of disease, localized prostate cancer, post-radical prostatectomy with non-rising prostate-specific antigen levels \< 0.1 ng/mL, cervical carcinoma of stage 1B or less, non-invasive, superficial bladder cancer or any curable cancer with a CR of \> 2 years duration.
. Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection or any known active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative, and Anti-HBs positive) will be eligible. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
. Cytomegalovirus (CMV)-PCR positive at baseline.
. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or interfere with the feasibility to administer study drugs including active hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), history of cutaneous collagenous vasculopathy and capillary leak syndrome.
. Concurrent treatment with another investigational agent or radiation therapy.