NCT06238648

Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy

Recruiting now Phase 2 Last updated 26 September 2024

What this trial tests

Phase 2 trial testing Biopsy in Diffuse Large B-Cell Lymphoma, Not Otherwise Specified in 120 participants. Currently enrolling.

Timeline

31 January 2024

Primary endpoint
31 December 2029

31 December 2030

Quick facts

Lead sponsor	Academic and Community Cancer Research United
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	31 January 2024
Primary completion	31 December 2029
Estimated completion	31 December 2030
Sites	6 locations across United States

Drugs / interventions tested

• Biopsy — full drug profile →
• Biospecimen Collection — full drug profile →
• Computed Tomography
• Epcoritamab (EPCORITAMAB) — full drug profile →
• Magnetic Resonance Imaging
• Patient Observation
• Positron Emission Tomography

Conditions studied

• Diffuse Large B-Cell Lymphoma, Not Otherwise Specified — all drugs for Diffuse Large B-Cell Lymphoma, Not Otherwise Specified →
• Primary Mediastinal Large B-Cell Lymphoma — all drugs for Primary Mediastinal Large B-Cell Lymphoma →
• Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma — all drugs for Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma →

Sponsor

Academic and Community Cancer Research United — full company profile →

Who can join

18 and older, any sex, with Diffuse Large B-Cell Lymphoma, Not Otherwise Specified or Primary Mediastinal Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial compares epcoritamab to standard practice (observation) for the treatment of patients with B-cell lymphomas who are not in complete remission after treatment with CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy. Epcoritamab is a bispecific antibody. It works by simultaneously attaching to a molecule called CD20 on cancerous B-cells and a molecule called CD3 on effector T-cells, which are a type of immune cell. When epcoritamab binds to CD20 and CD3, it brings the two cells together and activates the T-cells to kill the cancerous B-cells. Epcoritamab may increase a patient's chances of achieving complete remission after CD19-directed CAR-T therapy, compared to standard observation.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic landscape of primary refractory and relapsed diffuse large B-cell lymphoma: Recent advances and emerging therapies.
   Bock AM, Epperla N. · · 2025 · cited 8× · PMID 40597378 · DOI 10.1186/s13045-025-01702-5
2. The Development and Application of Bispecific Antibodies in B-Cell Non-Hodgkin Lymphoma.
   Sun L, Romancik JT. · · 2025 · cited 5× · PMID 39997328 · DOI 10.3390/jpm15020051
3. Bispecific Antibodies for Lymphoid Malignancy Treatment.
   Bisio M, Legato L, Fasano F, Benevolo Savelli C, et al · · 2024 · cited 4× · PMID 39796723 · DOI 10.3390/cancers17010094
4. Updates on Chimeric Antigen Receptor T-Cells in Large B-Cell Lymphoma.
   Saleh K, Khalife N, Arbab A, Khoury R, et al · · 2024 · cited 2× · PMID 39767716 · DOI 10.3390/biomedicines12122810
5. 2026 Update on the Management of Diffuse Large B-Cell Lymphoma.
   Chong EA, Tomasulo EB, Barta SK. · · 2026 · PMID 41654318 · DOI 10.1002/ajh.70229