NIPH Clinical Trials Search

Efficacy and Safety of Epcoritamab Following Chimeric Antigen Receptor T-Cell Therapy in Relapse or Refractory Large B-Cell Lymphoma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Large B-cell lymphomas
Date of first enrollment	13/04/2026
Target sample size	88
Countries of recruitment
Study type	Interventional
Intervention(s)	Epcoritamab monotherapy treatment is administered from day 30 to day 90 following CAR-T cell infusion. A total of 12 cycles are administered. Each cycle is 28 days in duration.

Outcome(s)

Primary Outcome	1-year progression free survival rate
Secondary Outcome	Overall survival rate Event free survival rate Duration of response rate Overall response rate Complete response rate

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 80age old
Gender	Both
Include criteria	Provisional registration 1.Aged 18 or over, but under 80 2.Diagnosed with the following recurrent or refractory large B-cell lymphoma Diffuse Large B-Cell Lymphoma Primary mediastinal B-cell lymphoma High-grade B-cell lymphoma 3.Despite undergoing bridging therapy, the condition either SD or PD, or tumour burden remains, or these outcomes are anticipated even before bridging therapy 4.Cases in which at least two standard treatments, including anti-CD20 monoclonal antibody preparations, have been ineffective or have relapsed following treatment, or cases where one standard treatment was ineffective or resulted in relapse after treatment, but are expected to meet Selection Criterion 3 even after bridging therapy. 5. PS 0 to 2 6. Written imformed concent provided Definitive registration 1.Despite undergoing bridging therapy, the condition either SD or PD, or tumour mass remains (MTV >= 80ml) by central image review (PET-CT) 2. PS 0 to 2
Exclude criteria	Provisional registration 1.Ineligible for the study judged by physicians Definitive registration 1.Having an active infectious disease 2.AST/ ALT levels are four times or more above the upper limit of normal 3.CrCl < 30mL/min 4.Having uncontrolled autoimmune disease 5.Having uncontrolled heart disease 6.Having uncontrolled mental illness 7.Having avtive central nervous system involvement 8.Having a history of other malignant tumours within the past two years 9.Having a history of treatment with epcoritamab 10.Using immunosuppressants at the time of definitive registration 11.Ineligible for the study judged by physicians