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

NCT07030699 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-070
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Lymphoma

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

Outcome Measures

Primary Outcomes (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)

  2 years

Study Arms (1)

Epcoritamab with Lenalidomide and Tafasitamab

EXPERIMENTAL

Epcoritamab: 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.

Drug: Epcoritamab; Drug: Lenalidomide; Drug: Tafasitamab

Interventions

Epcoritamab DRUG

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

Epcoritamab with Lenalidomide and Tafasitamab

Lenalidomide DRUG

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

Epcoritamab with Lenalidomide and Tafasitamab

Tafasitamab DRUG

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

Epcoritamab with Lenalidomide and Tafasitamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Genmab: collaborator
• Incyte Corporation: collaborator
• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lymphoma

Interventions

Lenalidomide; tafasitamab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Pallawi Torka, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pallawi Torka, MD

CONTACT

201-775-7808; torkap@mskcc.org

Paul Hamlin, MD

CONTACT

646-608-1667

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase 2, open label, single arm, single institution study.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)