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 range18 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Best overall response rate (BORR)
Timeframe: 12 months after the start of study therapy
✕. 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.