Phase II Study of Loncastuximab Tesirine and Epcoritamab Combination Therapy in Adults with Relapsed or Refractory Diffuse Large B-cell Lymphoma and Related Aggressive B-cell Lymphomas

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining two drugs, loncastuximab tesirine and epcoritamab, in patients with relapsed or refractory aggressive B-cell lymphoma, including diffuse large B-cell lymphoma DLBCL, high-grade B-cell lymphoma HGBL, and follicular lymphoma grade 3B. The study includes patients who have not received CAR-T cell therapy but failed first-line treatment, as well as those who have had CAR-T therapy and experienced failure. This is a phase II clinical trial aiming to assess toxicity and response rates in these patient groups. Participants receive loncastuximab tesirine intravenously with an initial dosing schedule followed by maintenance doses every 21 days in responding patients for up to six cycles. Epcoritamab is given as a subcutaneous injection with a step-up dosing during the first cycle, then weekly in cycles 2 and 3, biweekly in cycles 4 to 9, and monthly from cycle 10 to a maximum of 13 cycles. The trial includes a safety analysis after 20 patients start treatment and an interim efficacy analysis after 50 patients are recruited, with additional response assessments for CAR-T naive patients. During the study, participants undergo regular assessments including imaging by FDG-PETCT or MRI to evaluate tumor response, laboratory tests for organ function, and monitoring of adverse events up to 150 days after the last drug administration. The primary outcome is the best overall response rate measured 12 months after starting therapy. Secondary outcomes include progression-free and overall survival, response duration, and treatment-related safety events. The trial may last until April 2030, with 120 participants expected to be enrolled.

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