Follicular LymphomaPhase 2NCT05783609
Epcoritamab and Rituximab for First-line Follicular Lymphoma
A Phase 2 study testing Epcoritamab and Rituximab in people with Follicular Lymphoma and Low Grade Non-Hodgkin's Lymphoma, Adult, run by Reid Merryman, MD at 6 sites in United States.
Trial summary
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Low Grade Non-Hodgkin's Lymphoma, Adult
- What is being tested?
- Epcoritamab and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 21 Jun 2023to Feb 2030
- 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
- Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current or prior histologic transformation are excluded.
- No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed.
- Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:
- Symptomatic adenopathy
- Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC <1.5x109/L; absolute neutrophil count [ANC] <1.0x109/L, Hgb <10g/dL; or platelets <100x109/L)
- Constitutional symptoms (defined as persistent fevers >100.4 F, shaking chills, drenching night sweats, or loss of >10% of body weight within a 6 month period)
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- Any nodal or extranodal tumor mass >7 cm in maximum diameter
- >3 nodal sites of involvement >3 cm
- Local compressive symptoms or imminent risk thereof
- Splenomegaly (craniocaudal diameter > 16cm on CT imaging)
- Clinically significant pleural or peritoneal effusion
- Leukemic phase (>5x109/L circulating malignant cells)
- Rapid generalized disease progression
- Renal infiltration
- Bone lesions
- Patients cannot be in need of urgent cytoreductive chemotherapy (in the opinion of the treating investigator).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)
- Age ≥18 years.
- Adequate hematologic and organ function:
- Absolute neutrophil count > 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be >0.5x109/L
- Platelets > 75 x109/L, unless due to marrow involvement by lymphoma, in which case platelets must be >50 x109/L
- Estimated CrCl (Cockcroft Gault) ≥ 45ml/min
- Total bilirubin < 1.5 X ULN, unless Gilbert syndrome, in which case direct bilirubin must be < 1.5 x ULN
- AST/ALT < 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST/ALT must be <5 x ULN
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to provide a pre-treatment tumor sample by core needle or excisional surgical biopsy. A fresh biopsy is strongly encouraged, but an archival sample is acceptable if the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut and mounted on positively-charged glass slides. Preferably, 25 slides should be provided; if not possible, a minimum of 15 slides is required. Exceptions to this criterion may be made with approval of the Sponsor-Investigator.
- Willingness to remain abstinent or to use two effective contraceptive methods that result in a failure rate of <1% per year from screening until: (a) at least 3 months after pre-treatment with rituximab or 12 months after the last dose of epcoritamab, whichever is longer, if the patient is a male or (b) until at least 18 months after pre-treatment with rituximab or 12 months after the last dose of epcoritamab, whichever is longer, if patient is a female. Examples of contraceptive methods with a failure rate of <1% per year include:
- Tubal ligation, male sterilization, hormonal implants, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- Alternatively, two methods (e.g., two barrier methods such as a condom and a cervical cap) may be combined to achieve a failure rate of <1% per year. Barrier methods must always be supplemented with the use of a spermicide.
Who cannot join
- Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of >10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days) for symptom palliation is allowed, in which case patients should be off steroids prior to treatment start.
- Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event.
- Patients with stage I follicular lymphoma
- Patients who are candidates for radiation therapy with curative intent (in the opinion of the treating investigator)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
- Active HBV (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.
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- Known history of seropositivity for human immunodeficiency virus (HIV). Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of epcoritamab.
- Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 2 years.
- Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or limit adherence to study requirements.
- Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, unstable angina, coronary/peripheral artery bypass graft, cardiac arrhythmia (CTCAE grade 3 or higher), clinically significant ECG abnormalities, or cerebrovascular accident.
- Patients with New York Heart Association Class III or IV heart failure or known ejection fraction of <45%.
- Inability to comply with protocol mandated hospitalizations and restrictions.
- Patients who are pregnant, breast-feeding, or intending to become pregnant during the study.
- Prior solid organ or allogeneic stem cell transplantation.
- History of known or suspected hemophagocytic lymphohistiocytosis (HLH).
- History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- Patients with a remote history of, or well controlled, autoimmune disease who meet above criteria may be eligible to enroll after consultation with the Sponsor-Investigator.
- History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.
- Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.
- Active CNS lymphoma
- Neuropathy > grade 2. (CTCAE)
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab.
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.
- Chemotherapy and other non-investigational anti-neoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of epcoritamab.
- No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection. Subjects who do not meet SARS-CoV-2 infection eligibility criteria will be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:
- No signs/symptoms suggestive of active SARS-CoV-2 infection
- Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart
- Screening 12-lead ECG showing a baseline QTcF >470 msec.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Gottfried von Keudell, MD, gkeudell@bidmc.harvard.edu
Gottfried von Keudell, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Reid W Merryman, MD, 617-632-6844, Reid_Merryman@dfci.harvard.edu
Reid W Merryman, MD
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Yazeed Sawalha, MD, Yazeed.Sawalha@osumc.edu
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Esta Konkol, 414-805-4594, ekonkol@mcw.edu
Sumana Devata, MD
- Recruiting
Icahn School of Medicine at Mount Sinai Hospital
New York, New York, 10029
Divya Shah, divya.shah2@mssm.edu
Joshua Brody, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Danielle Wallace, MD, danielle_wallace@urmc.rochester.edu
About this study
Official title: A Phase 2 Study of Epcoritamab and Rituximab for First-line Treatment of Follicular Lymphoma
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma.
The names of the study drugs involved in this study are:
- Rituximab (a type of monoclonal antibody therapy)
- Epcoritamab (a T-cell bispecific antibody)
Read the detailed description
This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab and rituximab for patients with untreated follicular lymphoma (FL). Epcoritamab brings T cells and follicular lymphoma cells close together and activates the T cells to kill the lymphoma cells. Rituximab activates the immune system to kill the lymphoma cells.
The U.S. Food and Drug Administration (FDA) has not approved epcoritamab as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has approved rituximab as a treatment option for follicular lymphoma (FL).
The research study procedures include screening for eligibility, study treatment with evaluations, blood tests, bone marrow biopsies, and Computerized Tomography (CT) scans and Positron Emission Tomography (PET) scans.
Participants will receive study treatment for approximately 9-10 months and will be followed for up to 10 years.
It is expected that about 100 people will take part in this research study, 35 participants in the initial cohort and 65 patients in the expansion cohort.
Genmab and AbbVie are supporting this research study by providing one of the study drugs, Epcoritamab. Genmab is providing funding for the study.
- Being tested
- Epcoritamab, Rituximab
- Keywords
- Immunotherapy, Follicular Lymphoma, Low-grade Non-Hodgkin's Lymphoma
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Also called DuoBody-CD3xCD20, GEN3013
T-cell bispecific antibody, via subcutaneous injection
RituximabDrug
Also called Rituxan, MabThera
Chimeric anti-CD20 monoclonal antibody, via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Epcoritamab + Rituximab | Experimental | Participants will undergo study procedures as outlined:
* PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment.
* Cycle 1:
* Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab.
* Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab. (Day 15 of Epcoritamab dosage will be administered in the hospital.)
* Cycles 2 - 3:
--Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab.
* Cycles 4 - 9:
* Day 1 of 4 week cycle: Predetermined dose of Epcoritamab.
* Day 15 of 4 week cycle: Predetermined dose of Epcoritamab.
* Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment.
* Follow up visits for up to 5 years. Receives: Drug: Epcoritamab; Drug: Rituximab |
| Epcoritamab + Rituximab Expansion | Experimental | Participants will undergo study procedures as outlined:
* PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment.
* Cycle 1:
* Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab.
* Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab.
* Cycles 2 - 3:
--Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab.
* Cycles 4 - 9:
* Day 1 of 4 week cycle: Predetermined dose of Epcoritamab.
* Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment.
* Follow up visits for up to 5 years. Receives: Drug: Epcoritamab; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
EOT CMR rate defined as the proportion of participants achieving CR per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment: PET-CT, score 1, 2, or 3 with or without a residual mass on a 5-point scale (5PS) among all patients and separately in Cohorts A and B.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
Secondary outcomes (17)
Best Partial Metabolic Response (PMR) Rate
Best PMR rate defined as the proportion of participants achieving PR per Lugano 2014 criteria (protocol appendix B) ever on treatment: PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size or on CT, ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; no increase in non-measured lesions; spleen if enlarged must have regressed by >50% in length beyond normal.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
Best Objective Metabolic Response (OMR) Rate
Best OMR rate defined as the proportion of participants achieving CR or partial response (PR) per Lugano 2014 criteria (protocol appendix B) ever on treatment.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
EOT Partial Metabolic Response (PMR) Rate
EOT PMR rate defined as the proportion of participants achieving PR per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment: PET-CT Score 4 or 5 with reduced uptake compared with baseline and residual mass(es).
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
EOT Objective Metabolic Response (OMR) Rate
EOT OMR rate defined as the proportion of participants achieving CR or partial response (PR) per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
2-year Duration of Response (DOR)
2-year DOR is a probability estimated using the Kaplan Meier method; DOR is defined as the time measurement criteria are met for CR or PR (whichever is first recorded) per Lugano 2014 criteria (protocol Appendix B) until the first date that recurrent or progressive disease is objectively documented, or death due to any cause. CR and PR participants without events reported are censored at the last disease evaluation.
Measured: 2 years
2-year Duration of Complete Response (DOCR)
2-year DOCR is a probability estimated using the Kaplan Meier method; DOCR is defined as the time measurement criteria are met for CR per Lugano 2014 criteria (protocol Appendix B) until the first date that recurrent or progressive disease is objectively documented, or death due to any cause. CR participants without events reported are censored at the last disease evaluation.
Measured: 2 years
2-year Progression-free Survival (PFS)
2-year PFS is a probability estimated using the Kaplan Meier method; PFS is defined as the duration of time from study entry to documented disease progression (PD) or death. PD defined by Lugano 2014 criteria (protocol Appendix B).
Measured: 2 years
2-year Time-to-Next Treatment (TTNT)
2-y TTNT is a probability estimated using the Kaplan Meier method; TTNT is defined as the duration of time from the first dose of treatment until the time of initiation of new therapy, or censored at the date of last contact.
Measured: 2 years
2-year Overall Survival (OS)
2-year OS is a probability estimated using the Kaplan-Meier method; OS is defined as the time from study entry to death, or censored at date last known alive.
Measured: 2 years
Incidence of Histological Transformation
Histological transformation was defined as participants who have a biopsy showing diffuse large B-cell lymphoma (DLBCL). Incidence is the number of participants with histological transformation during or after treatment.
Measured: up to 10 years
Number of Participants with Cytokine Release Syndrome (CRS) by Grade
All grade CRS AEs regardless of attribution based on American Society of Transplantation and Cellular Therapy [ASTCT] Consensus grading as reported on case report forms are counted and maximum grade tabulated. Incidence by grade is then tabulated as the number of participants ever experiencing maximum grade during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Treatment-Related CRS Rate
All grade 3-5 CRS AEs with attribution of probably, possibly or definitely-related to treatment based on American Society of Transplantation and Cellular Therapy [ASTCT] Consensus grading as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 CRS AE of any type during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Number of Participants with Neurotoxicity by Grade
All grade neurotoxicity AEs regardless of attribution based on CTCAEv5 as reported on case report forms are counted and maximum grade tabulated. Incidence by grade is then tabulated as the number of participants ever experiencing maximum grade during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Treatment-Related Neurotoxicity Rate
All grade 3-5 neurotoxicity AEs with attribution of probably, possibly or definitely-related to treatment based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 neurotoxicity AE of any type during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Toxicity Rate
All grade 3-5 AEs regardless of attribution based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one grade 3-5 AE of any type during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Treatment-Related Toxicity Rate
All grade 3-5 AEs with attribution of probably, possibly or definitely-related to treatment based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 2-5 Treatment-Related Toxicity Rate
All grade 2-5 AEs with attribution of probably, possibly or definitely-related to treatment based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 2-5 AE of any type during the time of observation.
Measured: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start21 Jun 2023
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reid Merryman, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reid Merryman, MD, Dana-Farber Cancer Institute
- Investigators
- Reid Merryman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783609
- Sponsor's protocol ID
- 22-702
- Status last verified
- May 2026
- First submitted
- 13 Mar 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Epcoritamab and Rituximab for First-line Treatment of Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT05783609
- Acronym / sponsor ID
- 22-702
- Keywords
- Immunotherapy, Follicular Lymphoma, Low-grade Non-Hodgkin's Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Reid Merryman, MDUniversity, hospital or other
- Collaborators
- Genmab, AbbVie
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 24 Mar 2023 (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.
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma.
The names of the study drugs involved in this study are:
- Rituximab (a type of monoclonal antibody therapy)
- Epcoritamab (a T-cell bispecific antibody)
Detailed description
This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of epcoritamab and rituximab for patients with untreated follicular lymphoma (FL). Epcoritamab brings T cells and follicular lymphoma cells close together and activates the T cells to kill the lymphoma cells. Rituximab activates the immune system to kill the lymphoma cells.
The U.S. Food and Drug Administration (FDA) has not approved epcoritamab as a treatment for any disease.
The U.S. Food and Drug Administration (FDA) has approved rituximab as a treatment option for follicular lymphoma (FL).
The research study procedures include screening for eligibility, study treatment with evaluations, blood tests, bone marrow biopsies, and Computerized Tomography (CT) scans and Positron Emission Tomography (PET) scans.
Participants will receive study treatment for approximately 9-10 months and will be followed for up to 10 years.
It is expected that about 100 people will take part in this research study, 35 participants in the initial cohort and 65 patients in the expansion cohort.
Genmab and AbbVie are supporting this research study by providing one of the study drugs, Epcoritamab. Genmab is providing funding for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epcoritamab + Rituximab | Experimental | Drug: Epcoritamab, Drug: RituximabParticipants will undergo study procedures as outlined: * PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment. * Cycle 1: * Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab. * Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab. (Day 15 of Epcoritamab dosage will be administered in the hospital.) * Cycles 2 - 3: --Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab. * Cycles 4 - 9: * Day 1 of 4 week cycle: Predetermined dose of Epcoritamab. * Day 15 of 4 week cycle: Predetermined dose of Epcoritamab. * Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment. * Follow up visits for up to 5 years. |
| Epcoritamab + Rituximab Expansion | Experimental | Drug: Epcoritamab, Drug: RituximabParticipants will undergo study procedures as outlined: * PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment. * Cycle 1: * Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab. * Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab. * Cycles 2 - 3: --Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab. * Cycles 4 - 9: * Day 1 of 4 week cycle: Predetermined dose of Epcoritamab. * Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment. * Follow up visits for up to 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Histologically confirmed diagnosis of CD20+ FL (grade 1-3A) with review of the diagnostic pathology specimen at one of the participating institutions. Patients with current or prior histologic transformation are excluded.
- No prior systemic therapy for FL. Prior treatment with radiation therapy or short course steroids is allowed.
- Meets at least one criterion to begin treatment based on the modified GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria:
- Patients cannot be in need of urgent cytoreductive chemotherapy (in the opinion of the treating investigator).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. (Appendix A)
Key exclusion criteria (30 listed)
- Patients who require systemic immunosuppressive therapy for an ongoing medical condition will be excluded. For corticosteroids, patients receiving a prednisone dose of >10 mg daily (or equivalent) will not be eligible. A short course of steroids (up to 14 days) for symptom palliation is allowed, in which case patients should be off steroids prior to treatment start.
- Patients with bulky cervical adenopathy that is compressing the upper airway or could result in significant airway compression during a tumor flare event.
- Patients with stage I follicular lymphoma
- Patients who are candidates for radiation therapy with curative intent (in the opinion of the treating investigator)
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
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 |
|---|---|---|
| EpcoritamabAlso: DuoBody-CD3xCD20, GEN3013T-cell bispecific antibody, via subcutaneous injection | Drug | Epcoritamab + Rituximab, Epcoritamab + Rituximab Expansion |
| RituximabAlso: Rituxan, MabTheraChimeric anti-CD20 monoclonal antibody, via IV infusion | Drug | Epcoritamab + Rituximab, Epcoritamab + Rituximab Expansion |
Primary outcome
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
EOT CMR rate defined as the proportion of participants achieving CR per PET/CT Lugano 2014 criteria (protocol appendix B) at the EOT assessment: PET-CT, score 1, 2, or 3 with or without a residual mass on a 5-point scale (5PS) among all patients and separately in Cohorts A and B.
17 secondary outcomes
Best Partial Metabolic Response (PMR) Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
Best Objective Metabolic Response (OMR) Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
EOT Partial Metabolic Response (PMR) Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
EOT Objective Metabolic Response (OMR) Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days
2-year Duration of Response (DOR)
Time frame: 2 years
2-year Duration of Complete Response (DOCR)
Time frame: 2 years
2-year Progression-free Survival (PFS)
Time frame: 2 years
2-year Time-to-Next Treatment (TTNT)
Time frame: 2 years
2-year Overall Survival (OS)
Time frame: 2 years
Incidence of Histological Transformation
Time frame: up to 10 years
Number of Participants with Cytokine Release Syndrome (CRS) by Grade
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Treatment-Related CRS Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Number of Participants with Neurotoxicity by Grade
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Treatment-Related Neurotoxicity Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Toxicity Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 3-5 Treatment-Related Toxicity Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 days
Grade 2-5 Treatment-Related Toxicity Rate
Time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days + 30 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 22 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Reid Merryman, MD principal investigator
Dana-Farber Cancer Institute
6 sites 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 and Rituximab in people with Follicular Lymphoma and Low Grade Non-Hodgkin's Lymphoma, Adult, run by Reid Merryman, MD at 6 sites 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 29 inclusion and 30 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Reid Merryman, MD (617-632-3352, reid_merryman@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate (time frame: (Cycle 1 = 36 days, cycle 2-9 = 28 days), up to 267 days). 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 22 May 2026.