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LymphomaPhase 2ECLATNCT07030699

A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma

A Phase 2 study testing Epcoritamab, Lenalidomide and Tafasitamab in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The researchers are doing this study to find out whether the combination of epcoritamab with tafasitamab and lenalidomide is a safe and effective treatment for relapsed or refractory DLBCL. This is the first time the combination of drugs is being tested. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Epcoritamab, Lenalidomide and Tafasitamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
13 Aug 2025to 31 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Age ≥ 18 years
  • Pathologically confirmed diffuse large B cell lymphoma, transformed indolent lymphoma, primary mediastinal B cell lymphoma, high grade B cell lymphoma, follicular lymphoma grade 3B
  • Subjects must have histologically confirmed CD20+ lymphoma as documented in the most recent representative pathology report.
  • Presence of CD19 is not required to be confirmed (except if patients have received anti-CD19 therapy in the past). Patients treated with prior anti-CD19 therapy must have confirmation of CD19 expression in a biopsy done after progression on the last CD19 directed therapy.
  • At least 2 prior lines of systemic therapy including CART or ASCT (up to 4 prior lines of therapy allowed). Note that bridging therapy prior to ASCT or CART will be counted as a separate line of therapy)
  • At least one prior line of systemic therapy for patients ineligible for ASCT/CART or patients unwilling to undergo CAR-T/ASCT for logistic or other reasons (up to 4 prior lines of therapy allowed)
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  • Have radiologically measurable lymphadenopathy or extranodal involvement.
  • Eastern Cooperative Oncology Group performance status (PS) ≤ 2 (ECOG >2 can be enrolled if PS compromised from lymphoma e.g. spinal cord compression and expected to improve rapidly with therapy)
  • Must have adequate organ and marrow status Hemoglobin ≥8 g/dL (red blood cell transfusions are allowed)
  • Absolute neutrophil count (ANC) ≥1,000/mm^3 or ≥500/mm^3 if due to disease involvement in the bone marrow (G-CSF use is allowed).
  • Platelet count ≥75,000 cells/mm^3 or ≥50,000/mm^3 if due to disease involvement in the bone marrow (platelets transfusions are allowed)
  • Estimated Creatinine Clearance (CrCl) ≥40 mL/min (Cockcroft-Gault formula or other institutional standard methods)
  • Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN)
  • Direct bilirubin ≤ 2 x ULN (≤3 if due to Gilbert's syndrome or liver involvement by the lymphoma)
  • Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy for at least 1 year, have a CD4 count ≥ 200/μL, and have an undetectable viral load.
  • Signed Informed Consent Form(s)
  • Ability to comply with all the study-related procedures, in the investigator's judgement
  • Subject is willing to take aspirin prophylaxis (subjects with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event)
  • Contraception requirements
  • Patient is willing to adhere to pregnancy risk minimization plan associated with lenalidomide treatment.
  • For all females of child-bearing potential; a negative serum pregnancy test (beta-hCG) at the Screening Visit and a negative serum or urine pregnancy test at baseline prior to the first dose of study drug.
  • Female subjects of childbearing potential must practice at least 2 protocol-specified methods of birth control, that are effective from 30 days prior to treatment through at least 12 months after the last dose of study drug.
  • Female subjects of non-childbearing potential do not need to use birth control.
  • Female who is not pregnant, breastfeeding, donating eggs (ova, oocytes), or considering
  • becoming pregnant during the study or for 12 months after the last dose of study drug.
  • If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from 30 days prior to treatment initiation 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.
  • COVID19 eligibility criteria: Patient should 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 subject must have a negative molecular (e.g., 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.
  • Subjects 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

  • Prior CD3/CD20 BiAb based therapy with the following exceptions:
  • Patients who received prior CD3/CD20 BiAb as part of frontline therapy for DLBCL and were in remission for at least 1 year post frontline therapy are allowed
  • Patients who received prior CD3/CD20 BiAb as part of bridging therapy prior to CAR-T cell therapy without documentation of refractory/progressive disease on CD/CD30 BiAb are allowed
  • Patients who received prior CD3/CD20 BiAb and were in remission for at least 6 months after last dose of drug are allowed
  • Prior tafasitamab and/or lenalidomide therapy for lymphoma
  • Patients who received prior tafasitamab and/or lenalidomide as part of frontline therapy for DLBCL and were in remission for at least 1 year post frontline therapy are allowed
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  • Patient who received prior lenalidomide without evidence of intolerance or progression on drug are allowed
  • Active CNS involvement (previously treated CNS lymphoma is permissible)
  • Active secondary malignancy
  • Patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment is allowed e.g., low grade prostate cancer under surveillance
  • Patients with a previously treated malignancy should be eligible to participate if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease.
  • Other cases of active concurrent malignancies may be considered on a case-by-case basis if benefit outweighs risk after discussion with PI
  • Uncontrolled HIV or active HBV or HCV infection (controlled HIV with undetectable viral load, previously treated HBV and HCV are allowed if HBV DNA and HCV RNA are negative respectively, HBcAb positive with HBsAg negative disease is permitted if patient is willing to take entecavir prophylaxis)
  • Known active or latent tuberculosis
  • Prior solid organ transplantation
  • Prior allogeneic stem cell transplantation
  • Uncontrolled active systemic infection
  • Major surgery within 4 weeks of the first dose of study drug (exceptions may be allowed after discussion with PI if patient has fully recovered from procedure and anti-lymphoma therapy is urgently needed)
  • Known clinically significant cardiovascular disease, including:
  • Onset of unstable angina pectoris within 6 months of signing ICF
  • Acute myocardial infarction within 6 months of signing ICF
  • Uncontrolled congestive heart failure (grade III or IV as classified by the New York Heart Association)
  • Stroke or intracranial hemorrhage within 6 months prior to signing ICF In case of any other history of major cardiovascular disease, a cardiology consult is required within 60 days of enrollment
  • Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or risk study outcomes
  • Vaccination with live vaccines within 28 days prior to enrollment

About this study

Official title: Epcoritamab With Lenalidomide and Tafasitamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL)

The researchers are doing this study to find out whether the combination of epcoritamab with tafasitamab and lenalidomide is a safe and effective treatment for relapsed or refractory DLBCL. This is the first time the combination of drugs is being tested.

Conditions
Lymphoma
Being tested
Epcoritamab, Lenalidomide, Tafasitamab
Keywords
Large B cell lymphoma, Transformed indolent lymphoma, Primary mediastinal B cell lymphoma, High grade B cell lymphoma, Follicular lymphoma grade 3B, Epcoritamab, Lenalidomide, Tafasitamab, 25-070
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabDrug

    Subcutaneous, once weekly in cycles 1-3; every 4 weeks cycles 4-12

  • LenalidomideDrug

    Oral, daily on days 1-21 of a 28-day cycle

  • TafasitamabDrug

    Intravenous, once weekly during cycles 1-3, then every 2 weeks during cycle 4-12

Study groups in NCT07030699
Study groupRoleWhat they receive
Epcoritamab with Lenalidomide and TafasitamabExperimentalEpcoritamab: Subcutaneous, once weekly in cycles 1-3; every 4 weeks cycles 4-12. Tafasitamab: Intravenous, once weekly during cycles 1-3, then every 2 weeks during cycle 4-12. Lenalidomide: Oral, daily on days 1-21 of a 28-day cycle.
Receives: Drug: Epcoritamab; Drug: Lenalidomide; Drug: Tafasitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. best complete response rate (CRR)

    CR rate based on PET scan, as determined by the investigator according to the Lugano Response Criteria for Malignant Lymphoma (hereafter referred to as the 2014 Lugano Response Criteria)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2025
  2. Study start13 Aug 2025
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Why it stopped: Lack of accrual

Resources

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
Model description
This is a phase 2, open label, single arm, single institution study.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07030699
Sponsor's protocol ID
25-070
Acronym
ECLAT
Status last verified
Apr 2026
First submitted
12 Jun 2025
Last updated
7 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab, Lenalidomide and Tafasitamab in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center.

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 31 inclusion and 25 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: withdrawn, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

best complete response rate (CRR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030699.

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 7 Apr 2026.

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