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New antibody combo shows promise for Tough-to-Treat blood cancers

NCT ID NCT04623541

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This study tests an experimental antibody called epcoritamab, which helps the immune system target and kill cancer cells. It is being tested alone or with other drugs in about 194 people with relapsed/refractory chronic lymphocytic leukemia (CLL) or Richter's syndrome. The goal is to see if it is safe and effective, with treatment lasting up to 2 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Epcoritamab (an antibody that helps the immune system attack cancer cells), given alone or with other drugs like venetoclax, pirtobrutinib, lenalidomide, or R-CHOP chemotherapy.
What this could lead to
If successful, this could provide a new treatment option for people with hard-to-treat CLL or Richter's syndrome, potentially improving response rates and extending survival.
What could go wrong
This is an early-phase trial (1b/2), so safety and effectiveness are not yet proven. Side effects like cytokine release syndrome or nerve problems are possible, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

194 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. 2. Evidence of CD20 positivity in a sample representative of the disease at Screening. 3. Acceptable hematology parameters and organ function based on baseline bloodwork. 4. Life expectancy \>3 months on standard of care (SOC) for CLL, \>3 months for RS. 5. For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria. 6. For R/R CLL monotherapy arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor or at least 1 prior line of systemic antineoplastic therapy, including treatment with (or intolerance of) a covalent BTK inhibitor (cBTKi) and a B-cell lymphoma 2 (BCL-2) inhibitor. 7. For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL. 8. For all RS arms - Must have measurable disease by fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) or magnetic resonance imaging (MRI) scan. 9. For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample. 10. For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy 11. For RS - lenalidomide combination therapy arm * Deemed as ineligible for chemoimmunotherapy at the investigator's discretion, or participant who refuses to receive intensive chemotherapy. * Eligible for treatment with lenalidomide. * Must be willing to use contraception and adhere to the Lenalidomide Pregnancy Risk Minimization Plan * A woman must agree not to breastfeed a child during treatment and for at least 28 days after discontinuation from study. 12. For RS - R-CHOP combination Therapy Arm - * Eligible for treatment with R-CHOP. * Females of childbearing potential must use highly effective contraceptive measures while taking R-CHOP and for 12 months after stopping treatment. * A woman must agree not to breastfeed a child during treatment or until 12 months after last treatment. 13. For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy. * Presence of measurable disease. * Must take prophylaxis for tumor lysis syndrome (TLS). 14. For R/R CLL pirtobrutinib combination Therapy arm: * Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria. * Presence of measurable disease. * Previous treatment with at least one and a maximum 3 prior lines of therapy including a cBTKi. * Diagnosis of CLL/SLL that met published iwCLL criteria. 15. Non-US Participants Only - Participants with TN HR CLL - Pirtobrutinib Combination Therapy Expansion: * Diagnosis of CLL/SLL that met published iwCLL criteria 2018. * Must have active CLL/SLL disease that needs treatment per iwCLL * Must take prophylaxis for TLS based on their TLS risk evaluation upon initiation of trial drug. * Must have one or more high-risk features. * Presence of measurable disease. Key Exclusion Criteria 1. Received prior treatment with a CD3×CD20 bispecific antibody. 2. Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. 3. Received chimeric antigen receptor (CAR) T-cell therapy within 100 days or an investigational drug within 4 weeks, prior to first dose of trial drug. 4. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy. 5. Received vaccination with live vaccines within 28 days. 6. Clinically significant cardiac disease. 7. Known current malignancy other than inclusion diagnosis. 8. Has had major surgery within 4 weeks. 9. Known history of human immunodeficiency virus (HIV). 10. For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation. 11. For R/R CLL - Venetoclax Combination Therapy arm: received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial or has progressed on venetoclax treatment. 12. For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia. 13. RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS. 14. R/R CLL - Pirtobrutinib Combination Therapy Arm - Prior exposure to a non-covalent (reversible) BTK inhibitor or a BTK degrader. 15. Pirtobrutinib Combination Therapy Expansion Arms: * History of bleeding disorders or participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist * Require continuous treatment with or have received strong cytochrome P450 (CYP) 3A inhibitors or strong/moderate CYP3A inducers within 4 to 5 half-lives or 14 days prior to the first dose of pirtobrutinib. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Richter transformation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory chronic lymphocytic leukemia Richter's syndrome Small lymphocytic lymphoma Treatment-naïve high risk chronic lymphocytic leukemia

Contacts and locations

Locations

  • AOC Arcispedale Saint'Anna

    Coaña, Ferarra, Spain

  • AOU Arcispedale Sant'Anna

    Ferrara, Cona, 44124, Italy

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • AOU Policlinico Sant'Orsola Malpighi IRCCS

    Bologna, 00161, Italy

  • AOU Policlinico Umberto I

    Roma, 00161, Italy

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Aalborg University Hospital

    Aalborg, 9100, Denmark

  • Aidport sp z o.o.

    Skorzewo, Poland

  • Albert Schweitzer Ziekenhuis, Dordwijk

    Dordrecht, South Holland, 3318 AT, Netherlands

  • Alfred Health

    Melbourne, Victoria, 3004, Australia

  • Amsterdam UMC

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    Brescia, Italy

  • Barwon Health

    Geelong, Victoria, Australia

  • Bnai Zion Medical Center

    Haifa, Israel

  • CHU Clermont Ferrand

    Clermont-Ferrand, Puy De Dome, 63000, France

  • CHU Hôpital Haut-Lévêque Bordeaux

    Pessac, Gironde, 33404, France

  • CHU Hôpital de Brabois Nancy

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54500, France

  • CHU de Montpellier Hôpital Saint Eloi

    Montpellier, Cedex 5, 34090, France

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Chaim Sheba Medical Center

    Ramat Gan, Israel

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Columbia University Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • David Geffen School of Medicine

    Los Angeles, California, 90095, United States

  • Duke University Medical Center

    Durham, North Carolina, 27708, United States

  • Fakultni Nemocnice Ostrava

    Ostrava, Poruba, Czechia

  • Fakultni nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Nový Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Hackensack Meridian Hospital

    Hackensack, New Jersey, 07601, United States

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, Israel

  • Henry Ford Medical Group

    Detroit, Michigan, 48202, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, València, 46010, Spain

  • Hospital Universitario Fundacion Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hôpital Privé du Confluent

    Nantes, Pays de la Loire Region, 44000, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • Hôpital Universitaire Pitié-Salpêtrière

    Paris, 75013, France

  • IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST

    Meldola, Forli - Cesena, 47014, Italy

  • IRCCS Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00136, Italy

  • Istituto di Candiolo

    Torino, Candiolo, 10060, Italy

  • Maastricht University Medical Center

    Maastricht, Limburg, 6229 HX, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33024, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • National Institutes of Health

    Bethesda, Maryland, 20892, United States

  • Northwell Health Cancer Institute

    Lake Success, New York, 11043, United States

  • O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • Odense University Hospital

    Odense, 5000, Denmark

  • Ospedale Maggiore di Novara

    Novara, 28100, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Pratia Malopolskie Medical Center Krakow (Pratia Małopolskie Centrum Medyczne Krakow)

    Krakow, Poland

  • Pratia Medical Center Katowice (Centrum Medyczne Pratia Katowice)

    Katowice, Poland

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 4941492, Israel

  • Rigshospitalet

    Copenhagen, Capital Region, 2100, Denmark

  • Roskilde Sygehus

    Roskilde, 4000, Denmark

  • St. George Hospital

    Kogarah, New South Wales, Australia

  • Stanford Cancer Center

    Palo Alto, California, 94305, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The University of Texas Southwestern Medical Centre

    Dallas, Texas, 75390, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum

    Kiel, 24105, Germany

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University of California Davis Medical Center Sacramento

    California City, California, 95817, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48190, United States

  • University of Pennsylvania School of medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Vseobecna Fakultni Nemocnice

    Prague, Nové Město, 128 08, Czechia

  • Århus University Hospital

    Aarhus, 8000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.