Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06238648 · ClinicalTrials.gov registry record · Phase 2
Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy
A Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by Academic and Community Cancer Research United.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 6
- Study locations
NCT06238648: Recruiting Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, sponsored by Academic and Community Cancer Research United.
NCT06238648 is a Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified that is actively recruiting participants, run by Academic and Community Cancer Research United. The registered enrollment target is 120 participants, above the 51-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target (135% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06238648, a Phase 2 study of Primary Mediastinal Large B Cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, is actively recruiting participants, sponsored by Academic and Community Cancer Research United.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 6
- Study locations
Study Summary
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.
Primary Outcome
CR will be assessed using Lugano 2014 criteria. Complete response rate is defined as the number of patients who achieve objective status of CR divided by the total number patients in each arm. Primary analysis population will be used for this endpoint. The proportion of CR rate in each arm with corresponding confidence interval and p-value comparing the CR rate will be reported.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Epcoritamab
Study Locations (6)
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Siteman Cancer Center at Washington University - St Louis
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Memorial Sloan Kettering Cancer Center - New York
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-01-31 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
What NCT06238648 shows while recruiting
NCT06238648 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 51-participant average among 11 other Primary Mediastinal Large B Cell Lymphoma trials with a reported enrollment target (135% higher).
The record links to 3 conditions, with Primary Mediastinal Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06238648 lists 6 locations in 6 states (Minnesota, Missouri, New Jersey).
Frequently Asked Questions
What is clinical trial NCT06238648 about?
NCT06238648 is a clinical study titled "Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed CAR-T Therapy". 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 sim...
What is the current status of trial NCT06238648?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-01-31. Estimated completion is 2030-12-31.
What conditions does trial NCT06238648 study?
This clinical trial studies the following conditions: Primary Mediastinal Large B Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma-Recurrent.
What interventions are being tested in trial NCT06238648?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Epcoritamab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06238648?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06238648 being conducted?
This trial has 6 study locations across Minnesota, Missouri, New Jersey, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Mediastinal Large B Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06238648's enrollment target sits among peer trials
120 2nd of 11 the highest of 11 other Primary Mediastinal Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Mediastinal Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pembro Plus CAR T-cell Therapy in R/R in PMBCL
RECRUITING · Phase 2
-
Epcoritamab With Dose Adjusted Etoposide, Cyclophosphamide, Vincristine, Doxorubicin, Prednisone and Rituximab (EPOCH-R) for the Treatment of Aggressive B-Cell Non-Hodgkin Lymphoma
RECRUITING · Phase 2
-
Emapalumab Prevention of CAR-T Cell Associated Toxicities
RECRUITING · Phase 2
-
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
RECRUITING · Phase 1
-
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
RECRUITING · Phase 1
-
Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkin Lymphoma After CAR-T Treatment
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01174108 · 120 participants · Phase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
- NCT01627301 · 120 participants · NA
Sympathetic Overactivity in Post-traumatic Stress Disorder
- NCT02025023 · 120 participants · Phase 3
Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
- NCT02128906 · 120 participants · Phase 2
Radiotherapy With Cisplatin vs. Docetaxel-cetuximab in HNSCC: ERCC1 Biomarker Enrichment and Interaction Design
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI