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

Efficacy and Safety of Epcoritamab Following Chimeric Antigen Receptor T-Cell Therapy in Relapse or Refractory Large B-Cell Lymphoma - Epcoritamab.26

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs011260001
Enrollment
88
Registered
2026-04-13
Start date
2026-04-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large B-cell lymphomas

Interventions

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.

Sponsors

Teshima Takanori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
1-year progression free survival rate

Secondary

MeasureTime frame
Overall survival rate Event free survival rate Duration of response rate Overall response rate Complete response rate

Contacts

Public ContactHideki Goto

Hokkaido University Hospital

hidekigt@med.hokudai.ac.jp+81-11-706-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026