Recruiting

Phase 2

EpcoritamabEpcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06510361

Conditions

Lymphoma

Follicular Lymphoma

Lymphoma,Non-Hodgkin

Lymphoma, Non-Hodgkin's, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Epcoritamab

Study Details

Brief summary:

This research is being done to see if epcoritamab is effective in treating follicular lymphoma as a second line of treatment.

The name of the study drug in this research study is:

-Epcoritamab (a type of antibody)

Conditions

Lymphoma

Follicular Lymphoma

Lymphoma,Non-Hodgkin

Lymphoma, Non-Hodgkin's, Adult

Study ID

NCT06510361

Start date

Nov 20, 2024

Status verified date

Mar, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Biopsy-confirmed (fresh or archival tissue) follicular lymphoma grade 1-3A that is CD20+ (by immunophenotype or immunohistochemistry) at time of diagnosis. All degrees of CD20 positivity will be accepted. Composite high-grade lymphoma will be excluded.
Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm and short axis >1.0 cm and Deauville ≥ 4 seen on baseline PET/CT
Stage III/IV at initial diagnosis
1 prior line (at least 3 cycles) of systemic "upfront" or first-line therapy consisting of anti-CD20 antibody (e.g. obinutuzumab or rituximab) combined with chemotherapy (e.g. bendamustine, CHOP, CVP, or lenalidomide). Rituximab monotherapy, rituximab plus radiation, or radiation alone is not sufficient.
Subjects need to have achieved a partial response or stable disease as best response following upfront treatment. Subjects with progressive disease will be excluded.
Subjects must have completed all prior anti-lymphoma therapy at least 4 weeks (28 days) prior to start of epcoritamab.
Age ≥18 years.
3.1.7 Age ≥18 years.
ECOG performance status ≤ 2
Life expectancy of greater than 2 years
Participants must meet the following organ and marrow function as defined below:

Absolute neutrophil count ≥1000 cells/mcl (G-CSF allowed if marrow involved with disease)
Platelets ≥75,000 cells/mcl (transfusion allowed if marrow involved)
Hemoglobin ≥ 8 g/dL (transfusion allowed if marrow involved)
Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). In patients with suspected/known Gilbert's disease total bilirubin up to 3x ULN will be allowed
AST(SGOT)/ALT(SGPT) ≤3× institutional ULN unless suspected/known involvement by follicular lymphoma
Creatinine ≤ institutional ULN OR creatinine clearance \> 45 ml/min (by Cockcroft-Gault estimate or 24-hr creatinine clearance measurement)
Patients with hepatitis B core antibody positivity with negative PCR on antiviral therapy will be eligible but will be required to receive appropriate antiviral prophylaxis as described in Section 5.4. Patients with Hepatitis C antibody must have undetectable viral load.
Participants with a history of prior malignancy will be eligible if all treatment of that malignancy was completed at least 2 years prior to enrollment to this study, the treatment was considered "curable-intent", and there is currently no evidence of disease.
Resolution of toxicities from prior therapy to baseline or grade ≤1 (with the exception of grade 2 peripheral neuropathy or any grade alopecia)
Ability to understand and the willingness to sign a written informed consent document.
Females of childbearing potential must agree to practice a highly effective method of birth control (as defined by the EU Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials:

Established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception;
Placement of an intrauterine device (IUD) or intrauterine system (IUS);
Male partner sterilization (the vasectomized partner should be the sole partner for that patient)
True abstinence (when this is in line with the preferred and usual lifestyle of the patient)
Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab.
A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (i.e. use of condom) during the trial and for 12 months after receiving the last dose of epcoritamab.

Exclusion Criteria:

Use of investigational agents incorporated into prior induction therapy
Uncontrolled intercurrent active infection requiring hospitalization or intravenous antimicrobial agents within 4 weeks of start of treatment
Uncontrolled underlying cardiac conditions including but not limited to congestive heart failure grade III or IV (by NYHA) or EF <45%, unstable angina pectoris, acute myocardial infarction \< 6 months, cardiac arrhythmia
History of uncontrolled neurologic condition including but not limited to seizure disorder, stroke, psychosis, dementia, CNS vasculitis, encephalitis
EF <45% or need for supplemental O2 at rest to maintain SaO2>89%
Immunosuppressive therapy for non-lymphoma-related indication within 28 days (or for lymphoma within 10 days) of initiation of treatment, including systemic corticosteroids 10 mg/day or greater of prednisone or equivalent
Patients with known or suspected CNS involvement or leptomeningeal disease are excluded given concern for potentially increased risk of neurologic toxicity with epcoritamab. Patients with history of CNS malignancy from separate malignancy must have completed CNS-directed therapy and must currently have no evidence of disease
Pregnant or breastfeeding women or participants unwilling to adhere to institutional guidelines for highly effective contraception for the duration of the therapy are excluded. This is because of the unknown but potential risk of teratogenic or abortifacient effects, as well as potential for adverse events in nursing infants secondary to treatment of the mother, as epcoritamab has not yet been studied in this patient population. A female can be determined to not be of childbearing potential if she meets any of the following criteria:

Premenarchal
Postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone \[FSH\] level >40 IU/L or mIU/mL)
Permanently sterilized (e.g., bilateral tubal occlusion \[which includes tubal ligation procedures as consistent with local regulations\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy)

Note: If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 3.1.15.

Known current alcohol or drug abuse, psychiatric illness, or unstable social situation that is likely to limit compliance with study requirements
History of allergic reactions attributed to compounds of similar chemical or biologic composition to epcoritamab
Exposure to a live or a live attenuated vaccine within 4 weeks
Patients with HIV will be excluded

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Epcoritamab

35 participants will be enrolled and will complete study procedures as follows:

Baseline visit with imaging (CT, MRI or PET scan) and bone marrow biopsy.
Imaging after Cycles 3 and 6 only.
Cycles 1-3:

--Days 1, 8, 15 and 22 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily

Cycles 4-9:

--Days 1 and 15 of 28 day cycle: Predetermined dose of Epcoritamab 1x daily

Cycles 10-12:

--Day 1 of 28 day cycles: Predetermined dose of Epcoritamab 1x daily

End of Treatment visit with imaging and bone marrow biopsy.
Follow up: every 3 months for 2 years or until disease worsens.
Off study visit with imaging.

Interventions

Epcoritamab

Humanized IgG1 bispecific antibody, 5 or 60 mL vial, via subcutaneous (under the skin) injection per protocol.

Primary outcome measure

Complete Response Rate (CRR) [ Time Frame: CRR expected to be observed up to 12 months. ]

Central Contacts and Locations

Central contacts

Gottfried von Keudell, MD, PhD

617-667-9920 gkeudell@bidmc.harvard.edu

Dea Hunsicker, MSN

617-667-9920 dhunsick@bidmc.harvard.edu

Locations

Stanford

Recruiting

Stanford, California, United States, 94305

Contacts

Joseph Schroers-Martin, MD

jgsm@stanford.edu

Principal Investigator:

Joseph Schroers-Martin, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gottfried von Keudell, MPH, PhD

gkeudell@bidmc.harvard.edu

Dea Hunsickder, PhD

dhunsick@bidmc.harvard.edu

Principal Investigator:

Gottfried von Keudell, MD PhD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Joshua Brody, MD

joshua.brody@mssm.edu

Principal Investigator:

Joshua Brody, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

Follicular Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Non-Hodgkin's, Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-13.