Large B-cell LymphomaPhase 2EPCOR+LONCANCT06919939
Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
A Phase 2 study testing Epcoritamab and Loncastuximab Tesirine in people with Large B-cell Lymphoma and Relapse, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma, Relapse, DLBCL
- What is being tested?
- Epcoritamab and Loncastuximab Tesirine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to 7 Jan 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or older at the time of signing informed consent.
- Able and willing to sign the informed consent form (ICF).
- Ability to comply with the trial protocol.
- Relapsed/refractory (r/r) large B-cell lymphoma (LBCL) as determined by the local hematopathology laboratory from the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms (Swerdlow et al., 2016):
- LBCL or DLBCL, not otherwise specified (NOS)
- High-grade B-cell lymphoma (NOS or double/triple hit [technically classified in WHO 2016 as high-grade B-cell lymphoma (HGBCL), with Myc and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) translocations])
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- Transformed from follicular lymphoma, marginal zone lymphoma (MZL), and nodular lymphocyte predominant Hodgkin lymphoma
- Follicular lymphoma stage 3B
- Primary mediastinal B-cell lymphoma previously treated with checkpoint inhibitor Note: Relapsed disease is defined as disease that has recurred ≥6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy or progressed within 6 months (<6 months) of completion of therapy.
- Participants who have received at least one prior systemic therapy for LBCL including anti-cluster of differentiation 20 (anti-CD20) monoclonal antibody and anthracycline-containing therapy.
- Measurable disease by 2014 Lugano Classification. (Participants who have measurable disease, defined as at least 1 bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or at least 1 bi-dimensionally measurable extra nodal lesion, defined as >1.0 cm in its longest dimension.)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
- Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors within 72 hs):
- Absolute neutrophil count (ANC) ≥ 1.0 × 10^9 cells/L
- Hemoglobin ≥8.0 g/dL without blood transfusion in the past week
- Platelet count ≥75 × 10^9 platelets/L or ≥ 50 × 10^9 platelets/L if bone marrow involvement or splenomegaly
- Total bilirubin ≤1.5 × upper limit normal (ULN). Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible (≤3x institutional ULN if lymphoma involvement of the liver).
- Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤3.0 × ULN or ≤5 × ULN in the presence of liver involvement by lymphoma.
- i. Creatinine within normal institutional limits, or calculated creatinine clearance ≥40 mL/min by the Cockcroft-Gault Equation or other institutional standard methods
- Willingness to avoid pregnancy during the trial and for at least 12 months after the last dose of the trial intervention.
- Patients with history of human immunodeficiency virus (HIV) are eligible, provided they are stable on anti-retroviral therapy, have cluster of differentiation 4 (CD4) count ≥200/µL, and have an undetectable viral load. Note: HIV test is optional.
- Life expectancy of at least 12 weeks
- For patients receiving glucocorticoid treatment at screening: treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of epcoritamab.
Who cannot join
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.
- Prior treatment with anti-cluster of differentiation 19 (anti-CD19) chimeric antigen receptor T-cell (CAR-T) therapy
- Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies
- Prior autologous or allogenic stem cell transplant
- Known clinically significant pulmonary disease, including:
- Pulmonary fibrosis affecting patient's exercise tolerance.
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- Chronic obstructive pulmonary disease (COPD) affecting patient's exercise tolerance.
- Known clinically significant cardiac disease, including:
- Onset of unstable angina pectoris within 6 months of signing ICF
- Acute myocardial infarction within 6 months of signing ICF
- Congestive heart failure (grade III or IV as classified by the New York Heart Association
- Pregnant or breast feeding
- Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- Chronic or current active infectious disease (including severe acute respiratory syndrome (SARS) coronavirus 2 (CoV-2) requiring systemic antibiotics, antifungal, or antiviral treatment or any major episode of infection requiring treatment with intravenous (IV) antibiotics within 2 weeks of Day 1 of Cycle 1.
- Exposure to a live vaccine within 30 days of administration or anticipation that a live attenuated vaccine will be required during the study.
- Inactivated influenza vaccinations may be given during the influenza season.
- An approved coronavirus disease 2019 (COVID-19) vaccine (messenger ribonucleic acid (mRNA), inactivated virus, and replication deficient viral vector vaccines) is allowed.
- Active hepatitis B infection
- Patients who are hepatitis B surface antigen (HbsAg) negative and hepatitis B core antibody (HbcAb) positive must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation
- Active hepatitis C infection
- Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation
- Patient has no known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the patient must have a negative molecular (eg, PCR) test or 2 negative antigen test results at least 24 hours apart.
- Note: SARS-CoV-2 diagnostic tests should be applied following local requirements/recommendations. Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only rescreen if the following have been met:
- At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms.
- Patients with severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment.
- Patients with seizure disorder requiring therapy with a last convulsion within two years from enrollment.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Juan Alderuccio, MD, 305-243-4372, jalderuccio@med.miami.edu
Juan Alderuccio, MD
About this study
Official title: Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.
- Being tested
- Epcoritamab, Loncastuximab Tesirine
- Keywords
- DLBCL, Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma
- Medical subject headings
- Recurrence, Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Also called Epkinly
Epcoritamab will be administered via subcutaneous injection at the following dose levels and schedule over a total of twelve cycles:
- Cycle 1 Day 1: Step-up dose of 0.16 mg
- Cycle 1 Day 8: Step-up dose of 0.80 mg
- Cycle 1 Day 15: First full dose of 48 mg.
- Cycles 2 through 4 Days 1, 8 and 15: 48 mg
- Cycles 5 through 12 Days 1 and 15: 48 mg
Loncastuximab TesirineDrug
Also called Loncatuximab, Zynlonta
Loncastuximab will be administered intravenously (IV) at the following dose level and schedule over a total of four cycles:
- Cycles 1 and 2 Day 1: 120 mcg/kg
- Cycles 3 and 4 Day 1: 75 mcg/kg
- Cycle 4 Day 22: 75 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| EPCOR in combination with LONCA Treatment Group | Experimental | Participants in the Epcoritamab (EPCOR) in combination with Loncastuximab (LONCA) treatment group will receive up to 4 cycles of combination EPCOR and LONCA therapy, and an additional 8 cycles of EPCOR therapy, for a total of twelve treatment cycles. Cycles 1 through 3 last 21 days each; cycles four through 12 last 28 days each. Protocol therapy will last approximately 12 months.
Total participation duration is approximately 3 years. Receives: Drug: Epcoritamab; Drug: Loncastuximab Tesirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Cytokine Release Syndrome (CRS)-related Toxicity after Epcoritamab Administration
The number of participants experiencing Cytokine Release Syndrome (CRS) toxicity associated with Epcoritamab therapy will be reported, including Grades 2, 3 and 4. CRS-related toxicity will be assessed according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: Up to 14 months
Number of Participants Experiencing Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)-related Toxicity
The number of participants experiencing Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)-related toxicity including Grades 2, 3 and 4. ICANS-related toxicity will be assessed according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: Up to 14 months
Number of Participants Experiencing Neurologic Toxicities Associated with Epcoritamab
The number of participants experiencing neurologic toxicities associated with Epcoritamab therapy will be reported, including Grades 2, 3 and 4. Neurologic toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 14 months
Number of Participants Experiencing Fluid Accumulation Associated with Loncastuximab
The number of participants experiencing fluid accumulation associated with Loncastuximab therapy will be reported, including Grades 2, 3 and 4. Fluid accumulation toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 31 weeks
Number of Participants Experiencing Hepatotoxicity Associated with Loncastuximab
The number of participants experiencing hepatotoxicity (liver-related toxicity) associated with Loncastuximab therapy including Grades 2, 3 and 4 toxicity. Hepatotoxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 31 weeks
Secondary outcomes (4)
Overall Response Rate (ORR)
Overall response rate is defined as the number of participants with complete metabolic response (CMR) or partial metabolic response (PMR) as the best response. Response will be assessed according to Lugano 2014 criteria.
Measured: Up to 36 months
Partial Metabolic Response (PMR) Rate
PMR rate is defined as the number of participants with partial metabolic response (PMR) as the best response according to Lugano 2014 criteria.
Measured: Up to 36 months
Progression-Free Survival (PFS)
PFS is defined as the elapsed time in months from the start of treatment until disease progression or death, whichever is earlier. Participants who remain alive without progression will be censored at the last documented disease assessment date. Response will assessed according to Lugano 2014 criteria.
Measured: Up to 36 months
Overall Survival (OS)
OS is defined as the elapsed time in months from the start of treatment until death from any cause. Alive participants will be censored at the last date known to be alive.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start7 Jan 2026
- Primary completion7 Jan 2031 (estimated)
- Study completion7 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- ADC Therapeutics S.A., Genmab
- Responsible party
- Sponsor
- Investigators
- Juan Alderuccio, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919939
- Sponsor's protocol ID
- 20241140
- Acronym
- EPCOR+LONCA
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06919939
- Acronym / sponsor ID
- EPCOR+LONCA / 20241140
- Keywords
- DLBCL, Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- ADC Therapeutics S.A., Genmab
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 7 Jan 2031 (estimated)
- Study completion
- 7 Jan 2031 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPCOR in combination with LONCA Treatment Group | Experimental | Drug: Epcoritamab, Drug: Loncastuximab TesirineParticipants in the Epcoritamab (EPCOR) in combination with Loncastuximab (LONCA) treatment group will receive up to 4 cycles of combination EPCOR and LONCA therapy, and an additional 8 cycles of EPCOR therapy, for a total of twelve treatment cycles. Cycles 1 through 3 last 21 days each; cycles four through 12 last 28 days each. Protocol therapy will last approximately 12 months. Total participation duration is approximately 3 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Men and women aged 18 years or older at the time of signing informed consent.
- Able and willing to sign the informed consent form (ICF).
- Ability to comply with the trial protocol.
- Relapsed/refractory (r/r) large B-cell lymphoma (LBCL) as determined by the local hematopathology laboratory from the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms (Swerdlow et al., 2016):
- Participants who have received at least one prior systemic therapy for LBCL including anti-cluster of differentiation 20 (anti-CD20) monoclonal antibody and anthracycline-containing therapy.
Key exclusion criteria (27 listed)
- Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.
- Prior treatment with anti-cluster of differentiation 19 (anti-CD19) chimeric antigen receptor T-cell (CAR-T) therapy
- Prior exposure to bispecific T-cell engaging antiCD20XCD3 antibodies
- Prior autologous or allogenic stem cell transplant
- Known clinically significant pulmonary disease, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabAlso: EpkinlyEpcoritamab will be administered via subcutaneous injection at the following dose levels and schedule over a total of twelve cycles: * Cycle 1 Day 1: Step-up dose of 0.16 mg * Cycle 1 Day 8: Step-up dose of 0.80 mg * Cycle 1 Day 15: First full dose of 48 mg. * Cycles 2 through 4 Days 1, 8 and 15: 48 mg * Cycles 5 through 12 Days 1 and 15: 48 mg | Drug | EPCOR in combination with LONCA Treatment Group |
| Loncastuximab TesirineAlso: Loncatuximab, ZynlontaLoncastuximab will be administered intravenously (IV) at the following dose level and schedule over a total of four cycles: * Cycles 1 and 2 Day 1: 120 mcg/kg * Cycles 3 and 4 Day 1: 75 mcg/kg * Cycle 4 Day 22: 75 mcg/kg | Drug | EPCOR in combination with LONCA Treatment Group |
Primary outcome
Number of Participants Experiencing Cytokine Release Syndrome (CRS)-related Toxicity after Epcoritamab Administration
Time frame: Up to 14 months
The number of participants experiencing Cytokine Release Syndrome (CRS) toxicity associated with Epcoritamab therapy will be reported, including Grades 2, 3 and 4. CRS-related toxicity will be assessed according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Number of Participants Experiencing Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)-related Toxicity
Time frame: Up to 14 months
The number of participants experiencing Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS)-related toxicity including Grades 2, 3 and 4. ICANS-related toxicity will be assessed according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Number of Participants Experiencing Neurologic Toxicities Associated with Epcoritamab
Time frame: Up to 14 months
The number of participants experiencing neurologic toxicities associated with Epcoritamab therapy will be reported, including Grades 2, 3 and 4. Neurologic toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Number of Participants Experiencing Fluid Accumulation Associated with Loncastuximab
Time frame: Up to 31 weeks
The number of participants experiencing fluid accumulation associated with Loncastuximab therapy will be reported, including Grades 2, 3 and 4. Fluid accumulation toxicities will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Number of Participants Experiencing Hepatotoxicity Associated with Loncastuximab
Time frame: Up to 31 weeks
The number of participants experiencing hepatotoxicity (liver-related toxicity) associated with Loncastuximab therapy including Grades 2, 3 and 4 toxicity. Hepatotoxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 36 months
Partial Metabolic Response (PMR) Rate
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Alderuccio, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epcoritamab and Loncastuximab Tesirine in people with Large B-cell Lymphoma and Relapse, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Alderuccio, MD (305-243-4372, jalderuccio@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Cytokine Release Syndrome (CRS)-related Toxicity after Epcoritamab Administration (time frame: Up to 14 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.