Recurrent B-Cell Non-Hodgkin LymphomaPhase 2NCT06723457
Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
A Phase 2 study testing Biospecimen Collection, Computed Tomography and Epcoritamab in people with Recurrent B-Cell Non-Hodgkin Lymphoma and Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, run by Reem Karmali at 1 site in United States.
Trial summary
This phase II trial tests how well the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, Refractory B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Epcoritamab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 18 Feb 2029
- 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
- Patients must have a pathologically confirmed diagnosis of immunodeficiency-related large B-cell lymphoma as defined by the 5th Edition of the World Health Organization (WHO) Classification of Hematolymphoid Tumors 2022 in addition to any of the following:
- Lymphomas arising in immune deficiency which encompass monomorphic post-transplant lymphoproliferative disorder (PTLD) OR
- Polymorphic B-cell lymphoproliferative disorder arising in the setting of immunodeficiency and/or immune dysregulation as seen in 1 or more of the following settings:
- Underlying autoimmune disease
- Iatrogenic or therapy-related immunosuppression
- Conditions arising from inborn errors of immunity
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- Immune senescence as seen in patients aged ≥80 years or those ≥ 65 years with CD4 count < 500 cells/mm^3
- Epstein-Barr virus (EBV) infection as demonstrated by EBV positivity in the tumor cells
- Patients must have measurable disease (≥ 1 measurable nodal lesion [long axis > 1.5 cm] or ≥ 1 measurable extra-nodal lesion [long axis > 1.0 cm] on CT scan or MRI) per Lugano criteria
- Note; Patients with hepatomegaly /organomegaly deemed to be related to disease will also be eligible if not meeting strict Lugano criteria
- Patients must meet one disease status as follows AND deemed ineligible for chimeric antigen receptor T-cell (CAR-T):
- Primary refractoriness defined as a partial response or less on interim PET-CT during therapy with frontline chemo-immunotherapy (containing anti-CD20 monoclonal antibody)
- Primary refractoriness defined as a partial response or less on interim PET-CT during therapy with rituximab (or any other anti-CD20 monoclonal antibody) monotherapy AND deemed ineligible for escalation to chemotherapy
- Relapse after achieving a complete response with ≥ 1 prior systemic therapy (including CART)
- Patients must be aged ≥ 18 years
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Absolute neutrophil count (ANC) ≥ 1000/mcL (the use of growth factor support to attain goal ANC allowed, but not the last 14 days prior to screening laboratory test)
- Platelets (PLT) ≥ 50,000/mcL (transfusions allowed ≥ 7 days prior)
- Total bilirubin ≤ 1.5 Institutional upper limit of normal (ULN) unless attributed to Gilbert's ≤ 3 Institutional ULN if attributed to disease or Gilbert's
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x institutional ULN (> 3 and ≤ 5 x institutional upper limit of normal (ULN) if deemed related to disease)
- Glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m2
- Estimated (e)GFR is calculated by the abbreviated Modification of Diet in Renal Disease (MDRD)
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- The effects of lenalidomide on the developing human fetus are known. For this reason and because lenalidomide as well as other therapeutic agents used in this trial are known to be teratogenic, females of child-bearing potential (FOCBP) must agree to use adequate contraception. Female subjects of reproductive potential must either completely abstain from heterosexual sexual contact or must use 2 effective methods of contraception (at least 1 highly effective method and one effective method) at the same time
- The 2 effective contraceptive methods must be started at least 30 days before lenalidomide therapy, during therapy (including dose interruptions), and for at least 12 months following discontinuation of therapy
- Should a female patient become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Females should also refrain from egg donation from the time of informed consent, during the study and for 12 months after the last dose of study drug
- NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
- If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from 30 days prior to randomization through 12 months after the last dose of study drug, to practice the protocol-specified contraception
- Male who is not considering fathering a child or donating sperm during the study or for 12 months after the last dose of study drug
- FOCBP must have a negative pregnancy test prior to registration on study
- Patients must have no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- (If a patient has signs/symptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the patient must have a negative molecular (e.g., polymerase chain reaction [PCR]) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection)
- 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 after they meet the following SARS-CoV-2 infection viral clearance criteria:
- No signs/symptoms suggestive of active SARS-CoV-2 infection
- Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart)
Who cannot join
- Patients who have received any prior therapy with a bispecific T-cell engager targeting CD3 and CD20
- Patients who have received chemotherapy and/or other antineoplastic agents (except CD20- targeting monoclonal antibodies, steroids and/or radiation) within 1 week or 5 half-lives (whichever is shorter) prior to registration
- Patients who have undergone autologous stem cell transplant (ASCT) within 100 days of registration
- Patients who have undergone CAR-T therapy with refractoriness or relapse within 30 days of registration
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab and/or lenalidomide
- Patients with human immunodeficiency virus (HIV) with detectable viral load and CD4 count ≤350 cells/mm3 \& not on treatment for more than 1 year
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- Patients with evidence of active disease in the central nervous system (CNS) defined as either the presence of active lesions on MRI or cerebrospinal fluid (CSF) studies obtained within 4 weeks prior to registration or progressive neurological decline, attributable to CNS disease
- Patients who have a seizure disorder that is not controlled (requiring anti-epileptic therapy AND with seizure within 12 months of registration)
- Patients who have had major surgery within 4 weeks prior to registration
- Patients who have clinically significant cardiac disease include the following:
- Myocardial infarction or stroke within 6 months prior to enrollment,
- OR the following conditions within 6 months prior to enrollment: unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV), uncontrolled cardiac arrhythmia, and uncontrolled hypertension),
- OR Other clinically significant electrocardiogram (ECG) abnormalities within 6 months prior to enrollment unless deemed stable and appropriately treated
- OR Left ventricular ejection fraction < 45% for Echocardiogram
- Patients who are unable to swallow, retain and absorb oral tablet/gel/capsules
- Patients who have received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Note: Administration of killed vaccines is allowed
- Female patients who are pregnant or nursing.
- Note: Females should refrain from breast feeding from the time of informed consent, during the study and for 12 months after the last dose of study treatment
- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
- Ongoing or active infection requiring IV antimicrobial treatment
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
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
Northwestern University
Chicago, Illinois, 60611
Reem Karmali, MD, 312-695-0990, reem.karmali@northwestern.edu
Reem Karmali, MD
About this study
Official title: A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
This phase II trial tests how well the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that engages T-cells in the immune system to help redirect their killing effects against lymphoma cells. Lenalidomide can modulate the immune system to enhance killing effects of lymphoma by the immune system as well. Giving patients a combination of epcoritamab and lenalidomide may work better in treating refractory or relapsed immunodeficiency-related large B-cell lymphoma.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the six-month best response of complete response (CR) rate for the combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma.
SECONDARY OBJECTIVES:
- To evaluate the objective response rate (ORR), partial response (PR) and CR rates at 3 (cycle [C] 4 day [D]1), 6 (C7D1), 12 (30 days post C12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
II. To assess duration of response (DoR) at 6 (C7D1),12 (30 days post D12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
III. To assess progression free survival (PFS) with 12,18 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
IV. To assess overall survival (OS) with 12, 8 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
- To assess the safety and toxicity of combination epcoritamab-lenalidomide.
EXPLORATORY OBJECTIVES:
- To assess changes in immune-cell subsets with utilization of epcoritamab-lenalidomide.
II. To evaluate T cell polyfunctionality with the administration of combination epcoritamab-lenalidomide over time.
III. To gain more insights into the phenotype and functional state of different circulating immune cell subsets.
IV. To measure disease-specific symptoms and/or treatment-related concerns in patients treated with combination therapy using Functional Assessment of Cancer Therapy - Lymphoma (FACTLym) European Organization for Research and Treatment of Cancer (EORTC) and Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires.
OUTLINE:
Patients will receive epcoritamab subcutaneously (SC) weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients will also receive lenalidomide orally (PO) on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients will undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the study and may undergo magnetic resonance imaging (MRI) during screening.
After completion of study treatment, patients will be followed up at 30 days, then at 12, 18 and 24 months.
- Conditions
- Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, Refractory B-Cell Non-Hodgkin Lymphoma
- Being tested
- Biospecimen Collection, Computed Tomography, Epcoritamab, Lenalidomide, Magnetic Resonance Imaging
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
EpcoritamabBiological
Also called Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly
Given SC
LenalidomideDrug
Also called CC 5013, CC-5013, CC5013, CDC 501
Given PO
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (epcoritamab, lenalidomide) | Experimental | Patients receive epcoritamab SC weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients also receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT and collection of blood samples throughout the study and may undergo MRI during screening. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Epcoritamab; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best response of complete response (CR) rate
The combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma, indicated by the number of patients with CR as best response (using the Lugano Criteria) divided by the total number of patients who have received 1 dose of combination therapy and have had response assessment by radiographic imaging by 6 months from start of therapy. The six-month best response of CR rate will be estimated by the number of patients with complete response divided by the total number of patients who have received 1 dose of combination therapy and have had response assessment by radiographic imaging by 6 months from start of therapy. This estimation will be compared with the historical control 35% by Exact Test of one proportion. At the same time, the Blyth-Still-Casella exact binomial 95% confidence interval of this CR rate will be calculated with adjustment.
Measured: At 6 months
Secondary outcomes (5)
Objective response rate (ORR)
The ORR will be estimated by calculating the proportion of treated subjects who experience an objective response (confirmed CR or confirmed partial response [PR] per Lugano Criteria) among all evaluable patients. ORR data will be collected from the initiation of trial therapy (cycle [C] 1 day [D] 1) until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first). The ORR, PR and CR rates for patients on combination epcoritamab-lenalidomide, as well as their corresponding Blyth-Still-Casella exact binomial 95% confidence intervals, will be estimated for each time point at 3, 6, 12, 18 and 24 months.
Measured: From the initiation of trial therapy until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. This will be assessed at 3, 6, 12, 18, and 24 months.
Duration of response (DOR)
The DOR for combination epcoritamab-lenalidomide is defined as the elapses between the day of first documented response to trial therapy (CR or PR, whichever is recorded firstly) and subsequent disease progression (taking as reference for progressive disease the smallest tumor measurements recorded on study per Lugano Criteria), with possible censored at 6, 12, 18, or 24 months for different analysis. By the setting of multiple check and censor time points, the data will be released from cancer center as early as 6 months, which is a routine setting for cellular therapies For DOR analysis, response is defined as CR or PR per the 2014 Lugano Criteria; and disease progression is defined as progressive disease (PD) per the 2014 Lugano Criteria. The median of DOR censored at 6, 12, 18 and 24 months for patients on combination epcoritamab-lenalidomide will be estimated with 95% confidence interval. In addition, the DoRs at different time points will be descrived by Kaplan-Meier curve.
Measured: The elapses between the day of first documented response to trial therapy (CR or PR, whichever is recorded firstly) and subsequent disease progression, assessed at 6, 12, 18, and 24 months
Progression-free survival (PFS)
PFS data will be collected from initiation of trial therapy (C1D1) until the subject suffers disease progression, initiates subsequent anti-cancer therapy due to disease progression on study regimen, completes study participation, or experiences death from any cause (whichever is sooner). If disease progression or death from any cause is not observed prior to initiating subsequent anti-cancer therapy or completing study participation, the PFS will be censored at 12, 18 or 24 months during follow-up. The median of PFS with 12, 18, and 24 months of follow-up for patients on combination epcoritamab-lenalidomide, and corresponding 95% confidence interval, will be estimated. And the Kaplan-Meier curve will be employed again to visualize PFS.
Measured: From initiation of trial therapy to PD per the 2014 Lugano Criteria, other documented clinical or radiographical progression per physician judgement, or death due to disease, assessed at 12, 18, and 24 months
Overall survival (OS)
OS data will be collected from initiation of trial therapy (C1D1) until the patient completes study follow up participation, experiences death from any cause or is documented as lost to follow up per institutional standard (whichever is sooner). If death from any cause is not observed prior to completing study participation, the OS will be censored as the time of the last available documentation of survival status. The median of OS with 12, 18, and 24 months of follow-up for patients on combination epcoritamab-lenalidomide, and corresponding 95% confidence interval, will be estimated. And the Kaplan-Meier curve will be employed again to visualize OS.
Measured: The time that elapses between initiation of trial therapy and the date of death from any cause for all evaluable patients, assessed at 12, 18, or 24 months.
Incidence of adverse events
The toxicity profile of each study drug and combination of study drugs will be assessed. This endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution to one or both, according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start25 Jul 2025
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent B-Cell Non-Hodgkin 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reem Karmali
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Reem Karmali, Northwestern University
- Investigators
- Reem Karmali, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723457
- Sponsor's protocol ID
- NU 24H07
- Other IDs
- NCI-2024-09812, STU00222751, NU 24H07, P30CA060553
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06723457
- Acronym / sponsor ID
- NU 24H07
- Conditions
- Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, Refractory B-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Reem KarmaliUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2029 (estimated)
- First posted
- 9 Dec 2024 (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.
This phase II trial tests how well the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that engages T-cells in the immune system to help redirect their killing effects against lymphoma cells. Lenalidomide can modulate the immune system to enhance killing effects of lymphoma by the immune system as well. Giving patients a combination of epcoritamab and lenalidomide may work better in treating refractory or relapsed immunodeficiency-related large B-cell lymphoma.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the six-month best response of complete response (CR) rate for the combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma.
SECONDARY OBJECTIVES:
- To evaluate the objective response rate (ORR), partial response (PR) and CR rates at 3 (cycle [C] 4 day [D]1), 6 (C7D1), 12 (30 days post C12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
II. To assess duration of response (DoR) at 6 (C7D1),12 (30 days post D12), 18 and 24 months for patients on combination epcoritamab-lenalidomide.
III. To assess progression free survival (PFS) with 12,18 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
IV. To assess overall survival (OS) with 12, 8 and 24 months of follow-up for patients on combination epcoritamab-lenalidomide.
- To assess the safety and toxicity of combination epcoritamab-lenalidomide.
EXPLORATORY OBJECTIVES:
- To assess changes in immune-cell subsets with utilization of epcoritamab-lenalidomide.
II. To evaluate T cell polyfunctionality with the administration of combination epcoritamab-lenalidomide over time.
III. To gain more insights into the phenotype and functional state of different circulating immune cell subsets.
IV. To measure disease-specific symptoms and/or treatment-related concerns in patients treated with combination therapy using Functional Assessment of Cancer Therapy - Lymphoma (FACTLym) European Organization for Research and Treatment of Cancer (EORTC) and Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires.
OUTLINE:
Patients will receive epcoritamab subcutaneously (SC) weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients will also receive lenalidomide orally (PO) on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients will undergo positron emission tomography (PET)/computed tomography (CT) and collection of blood samples throughout the study and may undergo magnetic resonance imaging (MRI) during screening.
After completion of study treatment, patients will be followed up at 30 days, then at 12, 18 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (epcoritamab, lenalidomide) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Biological: Epcoritamab, Drug: Lenalidomide, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission TomographyPatients receive epcoritamab SC weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients also receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT and collection of blood samples throughout the study and may undergo MRI during screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Patients must have a pathologically confirmed diagnosis of immunodeficiency-related large B-cell lymphoma as defined by the 5th Edition of the World Health Organization (WHO) Classification of Hematolymphoid Tumors 2022 in addition to any of the following:
- Patients must have measurable disease (≥ 1 measurable nodal lesion [long axis > 1.5 cm] or ≥ 1 measurable extra-nodal lesion [long axis > 1.0 cm] on CT scan or MRI) per Lugano criteria
- Patients must meet one disease status as follows AND deemed ineligible for chimeric antigen receptor T-cell (CAR-T):
- Patients must be aged ≥ 18 years
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (22 listed)
- Patients who have received any prior therapy with a bispecific T-cell engager targeting CD3 and CD20
- Patients who have received chemotherapy and/or other antineoplastic agents (except CD20- targeting monoclonal antibodies, steroids and/or radiation) within 1 week or 5 half-lives (whichever is shorter) prior to registration
- Patients who have undergone autologous stem cell transplant (ASCT) within 100 days of registration
- Patients who have undergone CAR-T therapy with refractoriness or relapse within 30 days of registration
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab and/or lenalidomide
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Treatment (epcoritamab, lenalidomide) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Treatment (epcoritamab, lenalidomide) |
| EpcoritamabAlso: Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, EpkinlyGiven SC | Biological | Treatment (epcoritamab, lenalidomide) |
| LenalidomideAlso: CC 5013, CC-5013, CC5013, CDC 501Given PO | Drug | Treatment (epcoritamab, lenalidomide) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (epcoritamab, lenalidomide) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Treatment (epcoritamab, lenalidomide) |
Primary outcome
Best response of complete response (CR) rate
Time frame: At 6 months
The combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma, indicated by the number of patients with CR as best response (using the Lugano Criteria) divided by the total number of patients who have received 1 dose of combination therapy and have had response assessment by radiographic imaging by 6 months from start of therapy. The six-month best response of CR rate will be estimated by the number of patients with complete response divided by the total number of patients who have received 1 dose of combination therapy and have had response assessment by radiographic imaging by 6 months from start of therapy. This estimation will be compared with the historical control 35% by Exact Test of one proportion. At the same time, the Blyth-Still-Casella exact binomial 95% confidence interval of this CR rate will be calculated with adjustment.
5 secondary outcomes
Objective response rate (ORR)
Time frame: From the initiation of trial therapy until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. This will be assessed at 3, 6, 12, 18, and 24 months.
Duration of response (DOR)
Time frame: The elapses between the day of first documented response to trial therapy (CR or PR, whichever is recorded firstly) and subsequent disease progression, assessed at 6, 12, 18, and 24 months
Progression-free survival (PFS)
Time frame: From initiation of trial therapy to PD per the 2014 Lugano Criteria, other documented clinical or radiographical progression per physician judgement, or death due to disease, assessed at 12, 18, and 24 months
Overall survival (OS)
Time frame: The time that elapses between initiation of trial therapy and the date of death from any cause for all evaluable patients, assessed at 12, 18, or 24 months.
Incidence of adverse events
Time frame: Up to 24 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 8 Jul 2026.
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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.
Reem Karmali, MD principal investigator
Northwestern University
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 Biospecimen Collection, Computed Tomography and Epcoritamab in people with Recurrent B-Cell Non-Hodgkin Lymphoma and Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder, run by Reem Karmali 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 41 inclusion and 22 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 8 Jul 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 Study Coordinator (3126951301, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best response of complete response (CR) rate (time frame: At 6 months). 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 8 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.