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AzTrials

Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2BiFASTNCT07814001

Epcoritamab Plus Lenalidomide in Relapsed/Refractory Large B-cell Lymphoma After Second-Line CAR T-cell Therapy

A Phase 2 study testing Epcoritamab and Lenalidomide in people with Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Refractory Large B-cell Lymphoma (LBCL), run by The Lymphoma Academic Research Organisation at 15 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this Phase 2, open-label, multicenter clinical trial is to assess the efficacy and safety of accelerated ramp-up and fixed-dose subcutaneous epcoritamab combined with lenalidomide in adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) following progression after second-line CAR T-cell… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epcoritamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
15 sitesFrance
Study dates
Dec 2026to May 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

  • Participant (or their legally acceptable representative / trusted person) who understand and voluntarily signs and dates an informed consent form prior to any study-specific assessments/procedures being conducted
  • Aged ≥ 18 years at the time of signing the informed consent form (ICF) with no upper age limit
  • Diagnosis at relapse/progression post CAR T-cells of LBCL (de novo or histologically transformed from follicular lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2022 classification and documented in pathology report:
  • Diffuse large B-cell lymphoma (DLBCL), NOS
  • Large B-cell lymphoma (LBCL)
  • T-cell/histiocyte-rich large B-cell lymphoma
Show all 42Show fewer
  • Transformed follicular lymphoma
  • DLBCL/High-grade B cell lymphoma with MYC and BCL-2 translocations per WHO 2022.
  • High-grade B-cell lymphoma, NOS
  • Follicular lymphoma Grade 3B
  • Note: The following, non-exhaustive list of histologies excluded from enrollment: patients with CLL, Richter's, indolent non-Hodgkin lymphoma, transformed WM, transformed MZL and Burkitt lymphoma
  • Participant must have no prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20
  • Relapsing or refractory after two systemic lines of treatment including CAR T-cells therapy (Note: bridging therapy is not considered as a line of treatment)
  • R/R status will be determined by a PET scan performed approximately 1 month after CAR T cells infusion or on subsequent PET scans
  • Note: Participant who received a combination of CAR T-cells therapy and immunomodulatory drugs (IMids) as second line are not eligible
  • ECOG performance status 0 to 2
  • Presence of disease specific criteria allowing response evaluation:
  • Bi-dimensionally measurable disease defined by at least one lymph node > 15 mm or extranodal lesion > 10mm
  • At least one hypermetabolic lesion demonstrated by 18FDG PET-CT (PET0)
  • Adequate hematopoietic function at screening as follows (unless cytopenia is clearly due to bone marrow involvement, or hypersplenism):
  • Hemoglobin level > 8g/dL without RBC transfusion performed within 7 days before epcoritamab infusion
  • ANC ≥ 1 G/L (except if related to lymphoma involvement, ANC must be > 0.5 G/L)
  • Platelets ≥ 50 G/L without platelet transfusion performed within 7 days before epcoritamab (except if related to lymphoma, hypersplenism, platelets must be > 30 G/L)
  • Adequate renal function (calculated MDRD or Cockcroft-Gault): Creatinine Clearance ≥ 40 ml/min
  • Adequate liver function:
  • Total bilirubin ≤ 1.5 x ULN
  • Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are
  • accompanied by elevated indirect bilirubin are eligible
  • No persistent CAR-T neurotoxicity symptoms (regardless of grade)
  • Other adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (excepted the events previously described in criteria 8 to 11)
  • Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.
  • Participant must not have documented refractoriness to IMids and must be suitable for treatment with lenalidomide in the opinion of the investigator.
  • Note: Refractoriness to IMids is defined as:
  • Best response to prior IMids regimen of SD or PD, OR
  • Progressive disease within 6 months of completion of prior IMids regimen
  • Participant must not have had lenalidomide exposure within 12 months prior to screening.
  • Participant must be willing to take aspirin prophylaxis or prophylactic anticoagulation for thromboembolic event (or per local guidelines for lenalidomide administration).
  • Participant must be able to swallow capsules and must not have any disease significantly affecting gastrointestinal function (e.g., resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction).
  • Women of childbearing potential (WOCBP):
  • should have a negative result for pregnancy test (minimum sensitivity of 25mIU/mL, urine or serum) at screening
  • should agree to use at least one efficient method of birth control from 4 weeks prior to study treatment initiation, during study treatment administration and until 4 weeks after the last dose of lenalidomide and until
  • Men of reproductive potential should agree to use an acceptable method of birth control (condom) and must agree not to donate sperm during treatment and for 7 days after the last dose of lenalidomide and until 12 months after the last dose of epcoritamab

Who cannot join

  • Previously known CD20 negative status, excepted if a new biopsy or cytometry analysis proving a CD20 positive status is available before enrollment
  • Prior solid organ transplantation
  • Prior allogeneic SCT
  • Autologous SCT within 100 days prior to epcoritamab infusion
  • Known or current central nervous system or meningeal involvement by lymphoma
  • Current or past history of Progressive Multifocal Leukoencephalopathy (PML)
Show all 33Show fewer
  • Current or past history of aphasia, delirium, dementia, cerebellar disease, cognitive disorder, epilepsy under treatment, CNS vasculitis, neurodegenerative disease or dysarthria
  • History of cerebrovascular ischemia / hemorrhage with sequelae
  • Any serious psychiatric illness that would prevent the participant from signing the informed consent form
  • Patients with known active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to symptomatic SARS CoV-2 infection), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 1 week prior epcoritamab first injection Note: positive PCR EBV related to lymphoma could be enrolled
  • Known positive HTLV1 serology
  • Active Hepatitis C Virus (HCV) infection (RNA PCR-positive). Participants who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable,
  • Active Hepatitis B Virus (HBV) infection (DNA PCR-positive).
  • LVEF < 45% as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
  • Any serious active disease or co-morbid medical condition (such as New York Heart Association Class III or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including uncontrolled obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
  • Uncontrolled cirrhosis
  • Major surgery or significant traumatic injury < 28 days prior to the epcoritamab infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
  • Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception ofcorticosteroid treatment < 25 mg/day prednisone or equivalent within 2 weeks prior to epcoritamab first infusion. Inhaled and topical steroids are permitted.
  • Active malignancy other than the one treated in this Study.
  • Prior history of malignancies unless the participant has been free of the disease (in CR) for ≥ 2 years. However, participants with the following history/concurrent conditions are allowed:
  • Non-invasive basal cell or epidermoid carcinoma
  • In situ carcinoma of the cervix
  • In situ carcinoma of the breast
  • Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis [TNM] clinical staging system Note: Woman with adjuvant endocrine therapy (i.e., hormonotherapy) after breast cancer treatment can be enrolled if hormonotherapy was started for ≥ 2 years
  • Known or suspected hypersensitivity to the active substance or to any of the excipients.
  • Prior treatment within 4 weeks or five half-lives of the drug, whichever is shorter, before epcoritamab infusion with: - standard radiotherapy
  • any chemotherapeutic agent or treatment with any other investigational anti-cancer agents (defined as treatment for which there is currently no regulatory authority approved indication)
  • systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (e.g., anti-CTLA4, anti-PD1 and anti-PDL1) 23. Pregnant, planning to become pregnant or lactating or breastfeeding woman of childbearing potential
  • Pregnant, planning to become pregnant or lactating or breastfeeding woman of childbearing potential
  • Any significant medical conditions, or laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)
  • Participant deprived of his/her liberty by a judicial or administrative decision
  • Participant hospitalized without consent
  • Adult participant under legal protection

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stéphanie Doyen contact

+33 4 27 01 27 36

stephanie.doyen@lysarc.org

Nina Pronina contact

+33 (0)4 87 91 94 69

nina.pronina@lysarc.org

15 sites in 1 country

France15 sites

  • Hopital Henri Mondor

    Créteil, 94010

    Lemonnier François, Docteur, +33 (0)1 49 81 20 51, francois.lemonnier@aphp.fr

  • Chu Dijon Bourgogne

    Dijon, 21000

    Cédric Rossi, Professeur, +33 (0)6 80 29 50 41, cedric.rossi@chu-dijon.fr

  • Chu de Lille - Hopital Claude Huriez

    Lille, 59037

    Franck Morschhauser, Professeur, +33 (0)3 20 44 57 13, franck.morschhauser@chu-lille.fr

  • CHU de Limoges - Hopital Dupuytren

    Limoges, 87042

    Julie Abraham, Docteur, +33 (0)5 55 05 66 51, julie.abraham@chu-limoges.fr

  • Centre Léon Berard

    Lyon, 69373

    Sylvain Lamure, Docteur, +33 (0)4 69 85 61 93, sylvain.lamure@lyon.unicancer.fr

  • Institut Paoli Calmettes

    Marseille, 13273

    Jean-Marc Schiano De Colella, Docteur, +33 (0)6 13 21 04 91, schianojm@ipc.unicancer.fr

  • CHU de Montpellier

    Montpellier, 34925

    Charles Herbaux, Docteur, +33 (0)4 67 33 83 64, c-herbaux@chu-montpellier.fr

  • CHU de Nantes

    Nantes, 44093

    Benoit Tessoulin, Docteur, +33 (0)2 40 08 32 71, benoit.tessoulin@chu-nantes.fr

  • Hopital Necker

    Paris, 75743

    Morgane Cheminant, Docteur, +33 (0)1 44 49 52 83, morgane.cheminant@aphp.fr

  • CHU de Bordeaux - Hopital Haut-Leveque

    Pessac, 33604

    François-Xavier Gros, Docteur, +33 (0)5 57 65 65 11, francois-xavier.gros@chu-bordeaux.fr

  • CHU Lyon Sud

    Pierre-Bénite, 69495

    Pierre Sesques, Docteur, +33 (0)4 78 86 43 46, pierre.sesques@chu-lyon.fr

  • CHU de Poitiers - Hopital de la Miletrie

    Poitiers, 86021

    Stéphanie Guidez, Docteur, +33 (0)5 49 44 43 07, stephanie.guidez@chu-poitiers.fr

  • CHU Pontchaillou

    Rennes, 35033

    Guillaume Manson, Docteur, +33 (0)2 99 28 42 91, guillaume.manson@chu-rennes.fr

  • IUCT Oncopole

    Toulouse, 31059

    Lucie Oberic, Docteur, +33 (0)5 61 77 20 78, oberic.lucie@iuct-oncopole.fr

  • CHRU Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

    Arnaud Campidelli, Docteur, +33 (0)3 83 15 32 90, a.campidelli@chru-nancy.fr

Other trials in France

About this study

Official title: A Phase II Trial Evaluating Fixed Dose and Faster Ramp-up of Epcoritamab With Lenalidomide for 3L Relapse/Refractory Large B-cell Lymphoma After CAR T-cells Therapy in 2nd Line

The goal of this Phase 2, open-label, multicenter clinical trial is to assess the efficacy and safety of accelerated ramp-up and fixed-dose subcutaneous epcoritamab combined with lenalidomide in adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) following progression after second-line CAR T-cell therapy.

The main question it aims to answer is :

Read more
  • What is the overall response rate (ORR) after Cycle 2, or at premature treatment discontinuation (PTD), according to the 2014 Lugano Response Criteria?

Participants will:

  • Receive subcutaneous epcoritamab administered according to an accelerated ramp-up schedule followed by fixed dosing, in combination with lenalidomide.
  • Undergo clinical evaluations, laboratory assessments, and PET-CT imaging to determine disease status based on the 2014 Lugano Response Criteria.
  • Continue study therapy for up to 48 weeks.
  • Enter a follow-up period of at least 24 months after the last dose to monitor long-term outcomes and safety.

Approximately 55 adults will be enrolled across multiple centers in France. Eligible individuals must have R/R LBCL, including diffuse large B-cell lymphoma and other eligible LBCL subtypes, with progressive metabolic disease documented by PET-CT at least 1 month after second-line CAR T-cell therapy. The overall study duration is expected to be approximately 5 years.

Being tested
Epcoritamab, Lenalidomide
Keywords
Post CAR T cells therapy
Medical subject headings
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 DuoBody-CD3xCD20

    Epcoritamab will be administered subcutaneously in combination with lenalidomide. During Cycle 1, participants will receive an accelerated ramp-up dosing schedule consisting of 0.16 mg on Day 1, 0.8 mg on Day 3, and 48 mg on Days 8, 15, and 22. During Cycle 2, participants will receive 48 mg once weekly on Days 1, 8, 15, and 22. During the consolidation phase (Cycles 3 to 12), participants will receive 48 mg subcutaneously on Day 1 of each 28-day cycle.

  • LenalidomideDrug

    Lenalidomide will be administered orally in combination with epcoritamab from Cycles 2 through 12. Lenalidomide will be given once daily on Days 1 to 21 of each 28-day cycle, followed by a 7-day rest period (Days 22 to 28). The starting dose will be 20 mg for participants with creatinine clearance (CrCL) ≥60 mL/min and 10 mg for participants with CrCL between 30 and <60 mL/min, according to the study protocol.

Study groups in NCT07814001
Study groupRoleWhat they receive
Epcoritamab plus LenalidomideExperimentalAll enrolled participants will be included in a single cohort. No comparator group will be included.
Receives: Drug: Epcoritamab; Drug: Lenalidomide

What is being measured

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

  1. Overall Response Rate (ORR)

    Overall response rate (ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to the 2014 Lugano Response Criteria following treatment with accelerated ramp-up dosing and fixed-dose epcoritamab in combination with lenalidomide.

    Measured: At the end of Cycle 2 (each cycle is 28 days) or until premature treatment discontinuation (PTD) from any cause, whichever occurs first, assessed up to 56 days

Secondary outcomes (10)

  1. Best Overall Response Rate (Best ORR)

    Best overall response rate (Best ORR), defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as their best overall response according to the 2014 Lugano Response Criteria during study treatment.

    Measured: From Cycle 1 through the end of Cycle 8 (each cycle is 28 days) or until premature treatment discontinuation (PTD) from any cause, whichever occurs first, assessed up to 224 days.

  2. Complete Metabolic Response (CMR) Rate

    Proportion of participants achieving a complete metabolic response (CMR) according to the 2014 Lugano Response Criteria.

    Measured: At Cycles 1, 2, 5, 8, and 12 (each cycle is 28 days), assessed up to 336 days.

  3. Duration of Response (DoR)

    Duration of response (DoR), defined as the time from the first documented complete metabolic response (CMR) or partial metabolic response (PMR) according to the 2014 Lugano Response Criteria until the first documented disease progression, relapse, or death from any cause.

    Measured: From the date of first documented partial or complete response until the date of first documented disease progression, relapse, or death from any cause, whichever occurs first, assessed up to 54 months ( end of follow-up).

  4. Progression-Free Survival (PFS)

    Progression-free survival (PFS), defined as the time from the first dose of study treatment to the first documented disease progression according to the 2014 Lugano Response Criteria or death from any cause, whichever occurs first.

    Measured: From date of Cycle 1 (each cycle is 28 days)until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 54 months

  5. Overall Survival (OS)

    Overall survival (OS), defined as the time from the first dose of study treatment until death from any cause.

    Measured: From Cycle 1 ( 28 days) until date of death, or until end of follow-up (up to 54 months)

  6. Incidence of Tumor Lysis Syndrome (TLS)

    Number and proportion of participants experiencing tumor lysis syndrome (TLS), graded according to the protocol-specified toxicity criteria.

    Measured: From Cycle 1 until Cycle 12 ( each cycle is 28 days) or until the date of the permanent treatment discontinuation (PTD) or date of death from any cause, whichever occurs first. Assessed up to 336 days.

  7. Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)

    Number and proportion of participants experiencing ICANS.

    Measured: From Cycle 1 until Cycle 12 ( each cycle is 28 days) or until the date of the permanent treatment discontinuation (PTD) from any cause, whichever occurs first. Assessed up to 336 days

  8. Incidence of Cytokine Release Syndrome (CRS)

    Number and proportion of participants experiencing cytokine release syndrome (CRS).

    Measured: From Cycle 1 until Cycle 12 ( each cycle is 28 days) or until the date of the permanent treatment discontinuation (PTD) from any cause, whichever occurs first. Assessed up to 336 days

  9. Incidence of Cytopenias

    Number and proportion of participants experiencing treatment-emergent cytopenias.

    Measured: From Cycle 1 until Cycle 12 ( each cycle is 28 days) or until the date of the permanent treatment discontinuation (PTD) from any cause, whichever occurs first. Assessed up to 336 days

  10. Incidence of Infections

    Number and proportion of participants experiencing treatment-emergent infections.

    Measured: From Cycle 1 until Cycle 12 ( each cycle is 28 days) or until the date of the permanent treatment discontinuation (PTD) from any cause, whichever occurs first. Assessed up to 336 days

Timeline

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

  1. First posted10 Sep 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionMay 2031 (estimated)

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
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07814001
Sponsor's protocol ID
BiFAST
Acronym
BiFAST
Status last verified
Sep 2026
First submitted
19 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab and Lenalidomide in people with Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Refractory Large B-cell Lymphoma (LBCL), run by The Lymphoma Academic Research Organisation at 15 sites in France.

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 42 inclusion and 33 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. 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 Stéphanie Doyen (+33 4 27 01 27 36, stephanie.doyen@lysarc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: At the end of Cycle 2 (each cycle is 28 days) or until premature treatment discontinuation (PTD) from any cause, whichever occurs first, assessed up to 56 days). 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 NCT07814001.

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 10 Sep 2026.

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