Odronextamab in Low Tumor Volume Advanced FL

NCT07128641 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-008
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is:

• Odronextamab (a type of monoclonal antibody)

Conditions

Follicular Lymphoma; Lymphoma

Keywords

Follicular Lymphoma; Lymphoma; Treatment-naive Follicular lymphoma; Advanced Stage Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate (CRR)

  CRR is defined as the proportion of patients who accomplish a complete response (CR) as best response (CR rate) following treatment with odronextamab as per the revised Lugano criteria.

  Assessed at baseline and every 3 cycles, treatment lasts for 6 cycles, each cycle is 21 days.

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  Assessed at baseline and every 3 cycles, treatment lasts for 6 cycles, each cycle is 21 days.

• Median Progression Free Survival (PFS)

  Every 9 weeks in the first 18 weeks, then every 3 months for 2 years, then annually through year 5.

• Median Overall Survival (OS)

  Every 9 weeks in the first 18 weeks, then every 3 months for 2 years, then annually through year 15.

• Median time to next treatment (TTNT)

  Treatment lasts for 6 cycles, each cycle is 21 days.

• Median Duration of Response (DOR)

  Every 9 weeks in the first 18 weeks, then every 3 months for 2 years, then annually through year 5.

Study Arms (1)

Odronextamab

EXPERIMENTAL

Enrolled participants will complete: * Baseline visit with imaging and ECG * Cycle 1 (21 day cycle): --Days 1, 2, 8, 9, 15, and 16: Predetermined dose of Odronextamab 1x daily. * Cycle 2 (21 day cycle): * Day 1: tumor biopsy * Days 1, 8, and 15: Predetermined dose of Odronextamab 1x daily. * Cycle 3 through 6 (21 day cycles): * Imaging tests every 3 cycles * Day 1: Predetermined dose of Odronextamab 1x daily. * End of treatment: In-clinic visit with imaging, bone marrow biopsy and aspirate, and ECG. * Follow up: In-clinic visits with ECG and imaging. Visits will be every 3 months for 2 years and then annually for 3 years * Long term follow up: annually by phone * If 5 or fewer participants out of the first 17 participants do not have a complete response to the study drug, then enrollment will stop due to lack of efficacy. Safety will be monitored according to a specified Pocock-type stopping boundary per the protocol.

Biological: Odronextamab

Interventions

Odronextamab BIOLOGICAL

A CD20xCD3 bispecific monoclonal antibody, glass vials, via intravenous (into the vein) infusion per protocol.

Also known as: REGN1979

Odronextamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Lymph node biopsy obtained in the previous 6 months
• Subjects must have measurable disease at time of enrollment as defined by at least one lymph node with long axis ≥1.5 cm
• Age ≥18 years
• ECOG performance status \> 2
• Life expectancy of \> 2 years
• Participants must meet the following organ and marrow function as defined below:
• Absolute neutrophil count ≥1000 cells/mcl
• Platelets ≥100,000 cells/mcl
• Hemoglobin ≥ 10 g/dL
• Adequate organ function, as documented by:
• Cardiac ejection fraction \>40% by echocardiogram or multi-gated acquisition (MUGA) scan
• Total bilirubin ≤1.5 × upper limit of normal (ULN) (≤3 × ULN if attributed to lymphoma infiltration of liver)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if attributed to lymphoma infiltration of liver)
• Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if attributed to lymphoma infiltration of liver)

You may not qualify if:

• Participants must not meet any GELF Criteria for high tumor volume, or other circumstances for which immediate therapy would be indicated
• Any nodal or extranodal tumor mass \>7 cm diameter
• Involvement of at least 3 nodal sites, each with diameter \>3 cm
• Presence of any systemic or B symptoms for greater than 2 weeks (fever, night sweats, or weight loss)
• Splenic enlargement with inferior margin below the umbilical line
• Compression syndrome (ureteral, orbital, gastrointestinal)
• Pleural or peritoneal serous effusion (irrespective of cell content)
• Leukemic phase (\>5.0 x10⁹/L circulating malignant cells)
• Cytopenia (granulocyte count \< 1.0x10⁹/L and/or platelets \< 100x10⁹/L)
• Infections:
• Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other) at study enrollment or within 2 weeks of study enrollment, if requiring ongoing treatment and/or has the potential to cause disseminated disease or severe infection upon immunosuppression. There should be evidence that the infection has cleared or is well controlled by start of study therapy.
• Active symptomatic COVID-19 infection. Note, patients with prolonged PCR positivity (\>2 weeks after initial diagnosis) may be allowed to participate following discussion with the PI
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) NOTE: Participants with HIV who have controlled infection (undetectable viral load and CD4 count above 350 cells/μL either spontaneously or on a stable antiviral regimen) are permitted NOTE: Participants who are hepatitis B surface antigen positive or who are hepatitis B core antibody positive should undergo evaluation by a specialist and be considered to have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) before they are permitted onto study NOTE: Participants who are HCV antibody positive who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted
• Another active malignancy (aside from B-cell NHL) in the past 2 years, with the following exceptions: non-melanoma skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
• Limited-stage follicular lymphoma (stage I and limited stage II) with a possibility of treatment with a curative intent using radiotherapy

Sponsors & Collaborators

• Gottfried von Keudell, MD PhD: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gottfried Von Keudell, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gottfried Von Keudell, MD, PhD

CONTACT

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

Dea Hunsicker, MD, PhD

CONTACT

dhunsick@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 19, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): January 2, 2027
• Study Completion (Estimated): January 2, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)