CLL/SLLPhase 2NCT07108998
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL
A Phase 2 study testing Epcoritamab in people with CLL/SLL and CLL, run by Zulfa Omer at 1 site in United States.
Trial summary
This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Epcoritamab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 1 Jul 2029
- 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
- Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL/SLL and has received a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab for a minimum of 12 months as first line therapy.
- Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright ) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH/Cytogenetics translocations(del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL.
- Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab but detectable disease in blood or bone marrow by NGS ClonoSEQ.
- Age ≥18 years.
- ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).
- Patients must have adequate organ and marrow function as defined below:
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- Absolute neutrophil count ≥1,000/mcL, unless if neutropenia is due to underlying CLL bone marrow disease.
- Hemoglobin ≥8 g/dl unless if related to underlying CLL Platelets ≥50,000/ µL unless if related to underlying CLL Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (excepting Gilbert's syndrome, who may have a bilirubin > 1.5 × ULN, per discussion between the Investigator and the UC PI).
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN Glomerular filtration rate (GFR) Calculated GFR using CKD-EPI formula ≥ 30 (See Appendix E) or multiplying the estimate of GFR by an individual body surface area calculated using an appropriate formula and dividing by 1.73 m2.
- Women of childbearing potential and non-sterile males must practice at least 1 of the following methods of birth control with their partner(s) throughout the study and for 4 months after discontinuing study drug:
- Total abstinence from sexual intercourse as the preferred lifestyle of the patient; periodic abstinence is not acceptable.
- Surgically sterile partner(s) by vasectomy, bilateral orchiectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- Intrauterine device.
- Hormonal contraceptives (oral, parenteral, vaginal ring or transdermal) for at least 1-month prior to study drug administration.
- Women of childbearing potential must have a negative pregnancy result as follows: At Screening on a serum sample obtained within 7 days prior to the first study drug administration. If a urine pregnancy test at any timepoint during the study is positive or indeterminate, a serum pregnancy test will be performed for confirmation.
- Non-sterile males must refrain from sperm donation, from initial study drug administration until 4 months after the last dose of study drug.
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab as assessed by Adaptive's NGS ClonoSEQ.
- Absence of CD20 expression on CLL cells at pre-treatment.
- Received any prior treatment ever with a CD3×CD20 bispecific antibody.
- Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of beginning treatment on study.
- Receipt of a live vaccine within 28 days prior to study treatment initiation.
- Autoimmune diseases requiring high dose immunosuppressives (e.g., above 20 mg prednisone daily).
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- Central nervous system (CNS) disease(s) unless in the opinion of the investigator these would not preclude the patient from participation.
- Known hypersensitivity to any of the components of the treatment drugs (see Investigators Brochure for a list of components).
- Patients with active Richter's transformation.
- Note: the following will be eligible and not excluded: patients with accelerated phase or prolymphocytic progression
- Patients who have received prior radiation therapy (RT) unless in the opinion of the investigator the prior receipt of RT will not adversely impact the patient's ability to participate.
- Patients who require anti-coagulation with warfarin or equivalent Vitamin K antagonist.
- Major surgery within 14 days prior to the first dose of study drug.
- Patient has significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 180 days prior to the first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification or left ventricular ejection fraction ≤ 40%.
- Pregnant women, those planning to become pregnant during the study, and/or breastfeeding women are ineligible for participation.
- Patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). No new IV therapy or intravenous antibiotics may be initiated within 2 weeks prior to first dose of study drug.
- Known poorly controlled human immunodeficiency virus (HIV) or active hepatitis B or C infection (active hepatitis B defined as HBsAg positive, or HBcAb positive with detectable HBV DNA load; active hepatitis C defined as HCV antibody positive with HCV RNA positive)
- Unexplained fever > 38.3°C within 7 days prior to the first dose of study drug administration (if the fever is considered attributed to the patient's malignancy or an explained infection, the Patient may be enrolled at the discretion of the Investigator).
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zulfa Omer, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Christine Vollmer, 5132133203, mccordce@ucmail.uc.edu
Zulfa Omer, MD
About this study
Official title: A Phase 2 Study of Epcoritamab as a Consolidation Therapy for 2nd Generation BTKi +/- Obinutuzumab in CLL/SLL Patients or Variants of This.
This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this.
Read the detailed description
This is a Phase II, multicenter trial, where we seek to test the hypothesis that administration of up to 12 cycles of epcoritamab following a 12 months or greater time period of acalabrutinib +/- obinutuzumab or zanubrutinib +/- obinutuzumab in patients who have attained a partial response or better will have a high CR conversion rate with uMRD that enables discontinuation of therapy and lead to durable remission. Additionally, Patients attaining this exceptional uMRD CR at completion of therapy will have evidence of autologous T-cell response toward the patient pre-treatment CLL cells. A safety lead in of the combination for the first 9 patients followed by Simon's 2 stage design will be implemented. Following our inclusion and exclusion criteria, eligible patients will be treated with subcutaneous epcoritamab for a total of 12 cycles while continuing their BTKi therapy. Patients will be assessed for disease response as defined by the iw-CLL 2018 response criteria following completion of cycle 6 and 12 of epcoritamab by peripheral blood labs, CT imaging and bone marrow biopsy for morphology and flow cytometry (if labs/imaging indicating CR) and MRD status through NGS assay (ClonoSEQ). MRD will be performed from bone marrow samples if BMBx is done, and if not done peripheral blood sample will be used for MRD status. All patients who complete 12 cycles of epcoritamab consolidative therapy will have the ability to continue BTKi as monotherapy regardless of MRD status, pending discussion with the patient and treating-physician.
- Conditions
- CLL/SLL, CLL, SLL, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma Variant
- Being tested
- Epcoritamab
- Keywords
- Epcoritamab, Obinutuzumab
- 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.
EpcoritamabDrug
Epcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period.
| Study group | Role | What they receive |
|---|---|---|
| Epcoritamab + SOC | Experimental | Epcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period. Receives: Drug: Epcoritamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
uMRD CR as defined by negative leukemia cells to the 10^6
uMRD CR as defined by negative leukemia cells to the 10^6 after 12 cycles of consolidative therapy with epcoritamab measured by Adaptive's NGS MRD assay (ClonoSEQ) in patients who have attained a partial response or better with detectable disease after acalabrutinib or zanubrutinib +/- obinutuzumab treatment for a minimum of 12 cycles of therapy
Measured: Post 12 cycles (approximately 336 days after the start of first cycle) of consolidative therapy with epcoritamab
Secondary outcomes (5)
Safety measured by CTCAE v. 5.
Safety of epcoritamab given together with acalabrutinib or zanubrutinib in patients with CLL/SLL reported as frequency and severity of adverse events using CTCAE v. 5.
Measured: Day 1 of Cycle 1 to 60 days after end of C12D28 (i.e., approximately 396 days after the start of intervention)
uMRD CR defined by negative leukemia cells to the 10^6 using NGG ClonoSEQ
uMRD CR defined by negative leukemia cells to the 10^6 using NGG ClonoSEQ after 6 cycles of consolidation with epcoritamab.
Measured: Post 6 cycles (approximately 196 days after start of intervention) of consolidation with epcoritamab.
T-cell subsets levels measured by flow-cytometry
T-cell subsets levels (include T-regulatory cells, TH17 T-cells, effector memory T-cells, central memory T-cells, naïve T-cells, and cytotoxic T-cells) at baseline, Day 1, Day 8, C2D1, C4D1, C7D1 and C12 D28 of consolidation with epcoritamab.
Measured: Baseline, pre-treatment on Cycle1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 and end of Cycle 12. Each cycle is 28 days.
PFS defined as the interval between the first treatment day to the first sign of disease progression or death from any cause of patient
PFS defined as the interval between the first treatment day to the first sign of disease progression or death from any cause after receiving 12 cycles of consolidative epcoritamab.
Measured: Post 12 cycles of consolidative epcoritamab (approximately 364 days from start of intervention).. Each cycle is 28 days.
OS defined as time from starting treatment until death of patients
OS defined as time from starting treatment until death of patients after receiving 12 cycles of consolidative epcoritamab.
Measured: Post 12 cycles of consolidative epcoritamab (approximately 364 days from start of intervention).. Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start22 Aug 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLL/SLLStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zulfa Omer
- Sponsor type
- University, hospital or other
- Collaborators
- Genmab
- Responsible party
- Sponsor-investigator, Zulfa Omer, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108998
- Sponsor's protocol ID
- UCCC-HEM-24-01
- Other IDs
- IST-EPCO-00035
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Epcoritamab as a Consolidation Therapy for 2nd Generation BTKi +/- Obinutuzumab in CLL/SLL Patients or Variants of This.
- ClinicalTrials.gov ID
- NCT07108998
- Acronym / sponsor ID
- UCCC-HEM-24-01
- Conditions
- CLL/SLL, CLL, SLL, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Small Lymphocytic Lymphoma Variant
- Keywords
- Epcoritamab, Obinutuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Zulfa OmerUniversity, hospital or other
- Collaborators
- Genmab
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 study of Epcoritamab as a consolidation therapy for 2nd generation BTKi +/- Obinutuzumab in CLL/SLL patients or patients with variants of this.
Detailed description
This is a Phase II, multicenter trial, where we seek to test the hypothesis that administration of up to 12 cycles of epcoritamab following a 12 months or greater time period of acalabrutinib +/- obinutuzumab or zanubrutinib +/- obinutuzumab in patients who have attained a partial response or better will have a high CR conversion rate with uMRD that enables discontinuation of therapy and lead to durable remission. Additionally, Patients attaining this exceptional uMRD CR at completion of therapy will have evidence of autologous T-cell response toward the patient pre-treatment CLL cells. A safety lead in of the combination for the first 9 patients followed by Simon's 2 stage design will be implemented. Following our inclusion and exclusion criteria, eligible patients will be treated with subcutaneous epcoritamab for a total of 12 cycles while continuing their BTKi therapy. Patients will be assessed for disease response as defined by the iw-CLL 2018 response criteria following completion of cycle 6 and 12 of epcoritamab by peripheral blood labs, CT imaging and bone marrow biopsy for morphology and flow cytometry (if labs/imaging indicating CR) and MRD status through NGS assay (ClonoSEQ). MRD will be performed from bone marrow samples if BMBx is done, and if not done peripheral blood sample will be used for MRD status. All patients who complete 12 cycles of epcoritamab consolidative therapy will have the ability to continue BTKi as monotherapy regardless of MRD status, pending discussion with the patient and treating-physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| Epcoritamab + SOC | Experimental | Drug: EpcoritamabEpcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of CLL or SLL meeting the established 2018 iwCLL diagnostic criteria or variant of CLL/SLL and has received a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab for a minimum of 12 months as first line therapy.
- Attainment of Partial Response or greater with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab but detectable disease in blood or bone marrow by NGS ClonoSEQ.
- Age ≥18 years.
- ECOG performance status ≤2 (or Karnofsky ≥60%, see Appendix D).
- Patients must have adequate organ and marrow function as defined below:
Key exclusion criteria (20 listed)
- Obtaining a CR or nodal PR with no detectable disease in blood or bone marrow after treatment with a 2nd generation BTKi (acalabrutinib or zanubrutinib) +/- obinutuzumab as assessed by Adaptive's NGS ClonoSEQ.
- Absence of CD20 expression on CLL cells at pre-treatment.
- Received any prior treatment ever with a CD3×CD20 bispecific antibody.
- Organ transplant recipients are excluded except those with no active graft versus host disease (GVHD) requiring treatment within 12 months of beginning treatment on study.
- Receipt of a live vaccine within 28 days prior to study treatment initiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabEpcoritamab is the investigational product under study in combination with SOC drugs in this protocol. During C1, epcoritamab will be initiated using step-up dosing (SUD) C1D1 .16mg, C1D8 .8mg, C1D15 3 mg, C1D22 24 mg vs 48 mg (full dose) during safety lead in to determine the RP2D. On Cycles 2-3 the RP2D (24mg vs 48 mg) will be administered on Days 1, 8, 15, 22. Then Cycles 4-9 RP2D will be administered on Days 1 \& 15. Then Cycle 10-12 RP2D on Day 1 of each cycle. Epcoritamab is administered subcutaneously. The SOC BTKi are oral medications administered daily during the trial period. | Drug | Epcoritamab + SOC |
Primary outcome
uMRD CR as defined by negative leukemia cells to the 10^6
Time frame: Post 12 cycles (approximately 336 days after the start of first cycle) of consolidative therapy with epcoritamab
uMRD CR as defined by negative leukemia cells to the 10^6 after 12 cycles of consolidative therapy with epcoritamab measured by Adaptive's NGS MRD assay (ClonoSEQ) in patients who have attained a partial response or better with detectable disease after acalabrutinib or zanubrutinib +/- obinutuzumab treatment for a minimum of 12 cycles of therapy
5 secondary outcomes
Safety measured by CTCAE v. 5.
Time frame: Day 1 of Cycle 1 to 60 days after end of C12D28 (i.e., approximately 396 days after the start of intervention)
uMRD CR defined by negative leukemia cells to the 10^6 using NGG ClonoSEQ
Time frame: Post 6 cycles (approximately 196 days after start of intervention) of consolidation with epcoritamab.
T-cell subsets levels measured by flow-cytometry
Time frame: Baseline, pre-treatment on Cycle1 Day 1, Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 and end of Cycle 12. Each cycle is 28 days.
PFS defined as the interval between the first treatment day to the first sign of disease progression or death from any cause of patient
Time frame: Post 12 cycles of consolidative epcoritamab (approximately 364 days from start of intervention).. Each cycle is 28 days.
OS defined as time from starting treatment until death of patients
Time frame: Post 12 cycles of consolidative epcoritamab (approximately 364 days from start of intervention).. Each cycle is 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zulfa Omer, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epcoritamab in people with CLL/SLL and CLL, run by Zulfa Omer at 1 site in United States.
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 17 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uMRD CR as defined by negative leukemia cells to the 10^6 (time frame: Post 12 cycles (approximately 336 days after the start of first cycle) of consolidative therapy with epcoritamab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.