Relapsed/Refractory Chronic Lymphocytic LeukemiaPhase 1/2EPCORE™ CLL-1NCT04623541
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
A Phase 1/2 study testing Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone and Venetoclax in people with Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Genmab at 81 sites in 12 countries.
Trial summary
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as: Monotherapy, or Combination therapy: epcoritamab + venetoclax… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome
- What is being tested?
- Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 81 sitesin 12 countries
- Study dates
- 25 Nov 2020to Feb 2028
- Phase
- Phase 1/2
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
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
- Evidence of CD20 positivity in a sample representative of the disease at Screening.
- Acceptable hematology parameters and organ function based on baseline bloodwork.
- Life expectancy >3 months on standard of care (SOC) for CLL, >3 months for RS.
- For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
- 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.
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- For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL.
- 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.
- For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample.
- For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy
- 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.
- 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.
- 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).
- 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.
- 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.
Who cannot join
- Received prior treatment with a CD3×CD20 bispecific antibody.
- Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
- 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.
- Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
- Received vaccination with live vaccines within 28 days.
- Clinically significant cardiac disease.
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- Known current malignancy other than inclusion diagnosis.
- Has had major surgery within 4 weeks.
- Known history of human immunodeficiency virus (HIV).
- For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation.
- 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.
- For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
- RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS.
- R/R CLL - Pirtobrutinib Combination Therapy Arm - Prior exposure to a non-covalent (reversible) BTK inhibitor or a BTK degrader.
- 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.
Trial locations and contacts
81 sites in 12 countries.
81 sites in 12 countries
United States23 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48190
National Institutes of Health
Bethesda, Maryland, 20892
O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of California Davis Medical Center Sacramento
California City, California, 95817
University of Cincinnati
Cincinnati, Ohio, 45221
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
The University of Texas Southwestern Medical Centre
Dallas, Texas, 75390
Henry Ford Medical Group
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27708
Hackensack Meridian Hospital
Hackensack, New Jersey, 07601
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Northwell Health Cancer Institute
Lake Success, New York, 11043
Cedars-Sinai Medical Center
Los Angeles, California, 90048
David Geffen School of Medicine
Los Angeles, California, 90095
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford Cancer Center
Palo Alto, California, 94305
Memorial Healthcare System
Pembroke Pines, Florida, 33024
University of Pennsylvania School of medicine
Philadelphia, Pennsylvania, 19104
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Italy10 sites
AOU Policlinico Sant'Orsola Malpighi IRCCS
Bologna, Bologna, 00161
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
AOU Arcispedale Sant'Anna
Ferrara, Cona, 44124
IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Meldola, Forli - Cesena, 47014
Ospedale San Raffaele
Milan, 20132
Ospedale Maggiore di Novara
Novara, 28100
AOU Policlinico Umberto I
Roma, Roma, 00161
IRCCS Policlinico Universitario Agostino Gemelli
Rome, Lazio, 00136
Istituto di Candiolo
Torino, Candiolo, 10060
AOU Città della Salute e della Scienza di Torino
Torino, Torino, 10126
France7 sites
CHU Clermont Ferrand
Clermont-Ferrand, Puy de Dome, 63000
CHU de Montpellier Hôpital Saint Eloi
Montpellier, Cedex 5, 34090
Hôpital Privé du Confluent
Nantes, Pays de la Loire Region, 44000
Hôpital Saint-Louis
Paris, Paris, 75010
Hôpital Universitaire Pitié-Salpêtrière
Paris, Paris, 75013
CHU Hôpital Haut-Lévêque Bordeaux
Pessac, Gironde, 33404
CHU Hôpital de Brabois Nancy
Vandœuvre-lès-Nancy, Meurthe et Moselle, 54500
Spain7 sites
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona
AOC Arcispedale Saint'Anna
Coaña, Ferarra
Hospital Universitario Fundacion Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Virgen Macarena
Seville, Sevilla
Hospital Clinico Universitario de Valencia
Valencia, València, 46010
Denmark6 sites
Aalborg University Hospital
Aalborg, 9100
Århus University Hospital
Aarhus, 8000
Rigshospitalet
Copenhagen, Capital Region, 2100
Odense University Hospital
Odense, 5000
Roskilde Sygehus
Roskilde, 4000
Vejle Sygehus
Vejle, 7100
Australia5 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Barwon Health
Geelong, Victoria
St. George Hospital
Kogarah, New South Wales
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Alfred Health
Melbourne, Victoria, 3004
Czechia5 sites
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Králové, Nový Hradec Králové, 500 05
Fakultni nemocnice Olomouc
Olomouc, Czechia, 779 00
Fakultni Nemocnice Ostrava
Ostrava, Poruba
Vseobecna Fakultni Nemocnice
Prague, Nové Město, 128 08
Israel5 sites
Bnai Zion Medical Center
Haifa
Hadassah University Hospital - Ein Kerem
Jerusalem
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492
Chaim Sheba Medical Center
Ramat Gan
Tel Aviv Sourasky Medical Center
Tel Aviv
Netherlands5 sites
Amsterdam UMC
Amsterdam, 1105 AZ
Albert Schweitzer Ziekenhuis, Dordwijk
Dordrecht, South Holland, 3318 AT
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
Universitair Medisch Centrum Utrecht
Utrecht, Utrecht, 3584 CX
Belgium3 sites
AZ Sint-Jan
Bruges, 8000
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Leuven
Leuven, 3000
Poland3 sites
Pratia Medical Center Katowice (Centrum Medyczne Pratia Katowice)
Katowice, Poland
Pratia Malopolskie Medical Center Krakow (Pratia Małopolskie Centrum Medyczne Krakow)
Krakow, Poland
Aidport sp z o.o.
Skorzewo, Poland
Germany2 sites
Universitaetsklinikum Koeln
Cologne, 50937
Universitaetsklinikum Schleswig-Holstein- Karl-Lennart-Krebscentrum
Kiel, 24105
About this study
Official title: A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in
Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as:
Read more
- Monotherapy, or
- Combination therapy:
- epcoritamab + venetoclax
- epcoritamab + pirtobrutinib
In Non-United States (US) Participants Only: Treatment-naïve (TN) high risk (HR) (CLL):
- epcoritamab + pirtobrutinib
Combination therapy for Richter's Syndrome (RS):
- epcoritamab + lenalidomide
- epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine [Oncovin®] and prednisone).
The study includes participants with R/R or TN HR CLL (non-US participants only)/small lymphocytic lymphoma (SLL) and participants with RS.
The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Participants with RS are only included in the expansion phase.
Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, pirtobrutinib, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein).
Study details include:
- Study duration will be up to 5 years after the last participant's first treatment in the trial.
- The treatment duration for each participant will be between 12 months (1 year) and 24 months (2 years), depending upon the treatment arm assigned.
- The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study.
All participants will receive active drug; no one will be given placebo.
Read the detailed description
The purpose of the dose-escalation phase of the trial is to determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD; if reached) as well as establish the safety profile of epcoritamab monotherapy and epcoritamab + venetoclax in participants with R/R CLL.
The purpose of the expansion phase is to assess and evaluate the preliminary efficacy, safety and tolerability profiles of epcoritamab monotherapy, epcoritamab + venetoclax and epcoritamab + pirtobrutinib at the RP2D for participants with R/R CLL, TN HR CLL (in non-US participants only) and SLL. Along with this, epcoritamab monotherapy, epcoritamab + lenalidomide and epcoritamab + R-CHOP will be evaluated in participants with RS to assess their efficacy, safety and tolerability profiles.
The purpose of safety run-in phase for pirtobrutinib combination therapy is to evaluate the safety and tolerability profiles of pirtobrutinib in combination with epcoritamab.
- Conditions
- Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Treatment-naïve High Risk Chronic Lymphocytic Leukemia
- Being tested
- Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, Venetoclax, Lenalidomide, Pirtobrutinib
- Keywords
- DuoBody®, Bispecific antibodies, Anti-CD3, Anti-CD20
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabBiological
Also called EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Epcoritamab will be administered subcutaneously in cycles of 28 days, (except Cycle 1 for high-dose cohorts = 35 days).
EpcoritamabBiological
Also called EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Epcoritamab will be administered subcutaneously in cycles of 21 days and 28 days.
rituximab, cyclophosphamide, doxorubicin, vincristine and prednisoneDrug
R-CHOP will be administered intravenously (prednisone may be administered orally) in cycles of 21 days.
VenetoclaxDrug
Venetoclax tablets will be administered orally once daily during the 5-week ramp up period in cycles of 28 or 35 days each.
EpcoritamabBiological
Also called EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Epcoritamab will be administered subcutaneously in cycles of 28 days.
LenalidomideDrug
Lenalidomide capsules will be administered once daily for 21 days in each cycle of 28 days.
EpcoritamabBiological
Also called EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Epcoritamab will be administered subcutaneously in cycles of 28 days.
PirtobrutinibDrug
Pirtobrutinib tablets will be administered in cycles of 28 days.
EpcoritamabBiological
Also called EPKINLY™, GEN3013, DuoBody®-CD3xCD20
Epcoritamab will be administered subcutaneously in cycles of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Epcoritamab in R/R CLL/SLL | Experimental | In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase. Receives: Biological: Epcoritamab |
| Epcoritamab in RS | Experimental | Only in expansion phase. Receives: Biological: Epcoritamab |
| Epcoritamab + Venetoclax in R/R CLL/SLL | Experimental | In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase. Receives: Biological: Epcoritamab; Drug: Venetoclax |
| Epcoritamab + Lenalidomide in RS | Experimental | Only in expansion phase. Receives: Biological: Epcoritamab; Drug: Lenalidomide |
| Epcoritamab + R-CHOP in RS | Experimental | Only in expansion phase. Receives: Biological: Epcoritamab; Drug: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone |
| Epcoritamab + Pirtobrutinib in R/R CLL, TN HR CLL (Non-US Participants Only) and SLL | Experimental | Safety run-in and expansion phases. Receives: Biological: Epcoritamab; Drug: Pirtobrutinib |
| Fixed Duration Epcoritamab in R/R CLL/SLL | Experimental | Only in expansion phase. Receives: Biological: Epcoritamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Phase and Safety Run-in (R/R CLL arm): Number of Participants with Dose Limiting Toxicities (DLTs)
DLT events were defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Measured: During the first cycle for low dose cohorts (Cycle length = 28 days) and for high dose cohorts (Cycle length = 35 days)
Dose Escalation Phase and Safety Run-in: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 5 years
Dose Escalation Phase: Number of Participants with Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Clinical Tumor Lysis Syndrome (CTLS)
CRS and ICANS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria. CTLS will be graded according to Cairo-Bishop criteria.
Measured: Up to 5 years
Expansion Phase: Overall Response Rate (ORR)
R/R CLL participants will be assessed according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and the RS participants according to Lugano criteria. ORR based on the Lugano criteria is defined as the percentage of participants who achieve a response of PR or complete remission (CR), prior to initiation of subsequent therapy. The ORR based on the iwCLL criteria is defined as the percentage of participants who achieve a response of PR, CR with incomplete bone marrow recovery (CRi), or CR, prior to the initiation of subsequent therapy.
Measured: Up to 5 years
Secondary outcomes (20)
Expansion Phase: Number of Participants with TEAEs and SAEs
Measured: Up to 5 years
Dose Escalation Phase and Safety Run-in: ORR (for R/R CLL Participants)
The ORR is defined as the percentage of participants who achieve a response of PR, CRi, or CR, prior to the initiation of subsequent therapy as assessed by iwCLL criteria.
Measured: Up to 5 years
Both Phases and Safety Run-in: Duration of Response (DOR)
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Measured: Up to 5 years
Both Phases and Safety Run-in: Number of Participants with CR/CRi
CR and CRi for R/R CLL participants will be assessed according to iwCLL criteria and CR for the RS participants, according to Lugano criteria.
Measured: Up to 5 years
Both Phases and Safety Run-in: Time to Response (TTR)
TTR is defined among responders, as the time between first dose of any study drug and the initial documentation of response.
Measured: Up to 5 years
Both Phases and Safety Run-in: Progression Free Survival (PFS)
PFS is defined as the time from the first dosing date of any study drug and the date of disease progression or death, whichever occurs earlier.
Measured: Up to 5 years
Both Phases and Safety Run-in: Overall Survival (OS)
OS is defined as the time from the first dosing date of any study drug and the date of death due to any cause.
Measured: Up to 5 years
Both Phase and Safety Run-in: Time to Next Systemic Anti-cancer Therapy (TTNT)
TTNT is defined as the time from the first dosing date of any study drug to the first documented administration of subsequent systemic anticancer therapy.
Measured: Up to 5 years
Both Phases and Safety Run-in: Area Under the Concentration-time Curve (AUC) in Epcoritamab
Measured: Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days), up to 5 years
Both Phases and Safety Run-in: Maximum (Peak) Plasma Concentration (Cmax) in Epcoritamab
Measured: Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days), up to 5 years
Both Phases: Pre-dose (Trough) Concentrations (Cthrough) in Epcoritamab
Measured: Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days), up to 5 years
Both Phases and Safety Run-in: Time to Reach Cmax (Tmax) in Epcoritamab
Measured: Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days), up to 5 years
Both Phases and Safety Run-in: Elimination Half-life (T1/2) in Epcoritamab
Measured: Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days), up to 5 years
Both Phases and Safety Run-in: Total Body Clearance of Drug From Plasma (CL) in Epcoritamab
Measured: Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days), up to 5 years
Both Phases: Lymphoid Cells for Immunophenotyping
Evaluation of B cells, T cells and their activation
Measured: Up to 5 years
Expansion Phase: Number of Participants with CRS, ICANS and CTLS
CRS and ICANS will be graded based on ASTCT criteria. CTLS will be graded according to Cairo-Bishop criteria.
Measured: Up to 5 years
Expansion Phase and Safety Run-in : Percentage of Participants with Minimal Residual Disease (MRD) Negativity
MRD negativity rate, is defined as the proportion of participants with at least 1 undetectable MRD result according to the specific threshold, prior to initiation of subsequent therapy.
Measured: Up to 5 years
Both Phases and Safety Run-in: Number of Participants with Anti-drug Antibodies (ADA) to Epcoritamab
Measured: Up to 5 years
Expansion Phase: Number of Participants with PR
Measured: Up to 5 years
Both Phases and Safety Run-in: Duration of MRD Negativity
The time from first achieving MRD negativity after start of treatment to the MRD conversion to positive.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start25 Nov 2020
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed/Refractory Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie, Eli Lilly and Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623541
- Sponsor's protocol ID
- GCT3013-03
- Other IDs
- 2020-000848-57, NL74221.056.20, MOH_2023-04-02_012496, 2023-504828-25-00, 1006575, RECF-005228, 2023
- Acronym
- EPCORE™ CLL-1
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Kater AP, Janssens A, Eradat H, Offner F, Sandoval-Sus JD, Shadman M, Poulsen CB, Christensen JH, Thompson MC, Guan M, Steele AJ, Rios M, Holst Morch M, Oki T, Valentin R, Bellido M, Eichhorst B. Epcoritamab monotherapy for Richter transformation (EPCORE CLL-1): findings from a single-arm, multicentre, open-label, phase 1b/2 trial. Lancet Haematol. 2026 Jan;13(1):e8-e21. doi: 10.1016/S2352-3026(25)00327-8. Epub 2025 Dec 8.
PubMed 41380698