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Monoclonal Antibodies

Odronextamab for Lymphoma (ELM-1 Trial)

Phase 1
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm documented by CT or MRI scan, if CT scan is not feasible
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Must not have
Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug
Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection (as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, given either intravenously or subcutaneously. The first part of the trial is testing different doses of the drug to see how well it works, and the second part is testing how well it works in a larger group of people.

Who is the study for?
This trial is for people with certain B-cell blood cancers (like lymphoma or leukemia) that haven't responded to previous treatments. Participants must have good bone marrow function, a specific performance status, and measurable cancer lesions. They can't join if they've had recent chemotherapy, CNS issues, HIV/HBV/HCV infections, or live vaccinations within the last month.
What is being tested?
The study tests Odronextamab at various doses in two parts: Part A uses IV administration for dose escalation/expansion in B-NHL and CLL patients; Part B explores subcutaneous administration for dose finding/expansion specifically in B-NHL patients.
What are the potential side effects?
While not explicitly listed here, potential side effects of Odronextamab may include reactions at the infusion site (for IV), skin reactions (for SC), general immune responses like fever or fatigue, and possibly effects on blood counts or organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor larger than 1.5 cm that can be measured by a scan.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had chemotherapy or radiotherapy for lymphoma in the last 28 days.
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I do not have HIV, HBV, HCV, or CMV infections.
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I have a history of serious brain conditions or injuries.
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My cancer involves the brain or nervous system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Antitumor activity as measured by the objective response rate (ORR)
Safety/dose limiting toxicities (DLTs)
Safety/overall frequency of adverse events (AEs)
Secondary study objectives
Duration of Complete Response (DOCR)
Duration of response (DOR)
Incidence of anti-drug antibodies (ADA) to odronextamab
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part AExperimental Treatment1 Intervention
DLBCL post CAR-T
Group II: 2N Part BExperimental Treatment1 Intervention
DLBCL
Group III: 1N Part BExperimental Treatment1 Intervention
FL

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
667 Previous Clinical Trials
385,813 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
283 Previous Clinical Trials
254,882 Total Patients Enrolled

Media Library

Odronextamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02290951 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: 2N Part B, Part A, 1N Part B
Chronic Lymphocytic Leukemia Clinical Trial 2023: Odronextamab Highlights & Side Effects. Trial Name: NCT02290951 — Phase 1
Odronextamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02290951 — Phase 1
~16 spots leftby Sep 2025
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