Odronextamab in Low Tumor Volume Advanced FL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Gottfried von Keudell, MD PhD
Study ID
NCT07128641
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Sep 8, 2025
Status verified
Mar 2026
Primary completion
Jan 2, 2027
Completion
Jan 2, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Odronextamab
    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.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: Assessed at baseline and every 3 cycles, treatment lasts for 6 cycles, each cycle is 21 days. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Gottfried Von Keudell, MD, PhD
[email protected]
617-667-9920
Gottfried Von Keudell, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center· Boston, MA

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