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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

ELM-1 Trial 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.Check my eligibility

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.See study design

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.

ELM-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

ELM-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antitumor activity as measured by the objective response rate (ORR)

Safety/dose limiting toxicities (DLTs)

Safety/overall frequency of adverse events (AEs)

Secondary outcome measures

Duration of Complete Response (DOCR)

Duration of response (DOR)

Incidence of anti-drug antibodies (ADA) to odronextamab

+7 more

ELM-1 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

615 Previous Clinical Trials

379,647 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

259 Previous Clinical Trials

250,844 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other research projects examined the efficacy of multiple doses of Odronextamab?

"The initial assessments of odronextamab multiple dose levels were conducted in 2015 at Beth Israel Deaconess Medical Center. As of today, there are no completed trials; however, 3 studies remain ongoing with some taking place in New Brunswick, New jersey."

Answered by AI

Does this experiment represent a pioneering effort in its field?

"As of now, 3 clinical trials for Odronextamab multiple dose levels are ongoing throughout 46 cities and 15 different nations. These investigations were initiated in 2015 when Regeneron Pharmaceuticals sponsored a Phase 1 drug approval study with 298 participants; however, none have been completed since then."

Answered by AI

How many locations are currently conducting this research?

"This clinical trial is being conducted at 8 separate sites, with the most notable ones located in Massachusetts General Hospital (New Brunswick), Rutgers Cancer Institute of New jersey (New york) and Weill Cornell Medical College (Stanford)."

Answered by AI

Is this trial currently accessible to participants?

"Affirmative. Clinicaltrials.gov data confirms that this research is still open for enrollment, having been initially posted on the 9th of January 2015 and last updated on 4th November 2022. The investigation requires 298 volunteers from 8 different clinical trial sites."

Answered by AI

What is the principal aim of this clinical investigation?

"This medical trial, which is estimated to last 24 months and be supervised until completion, seeks to assess the overall safety of odronextamab. Secondary objectives include evaluating peak plasma concentrations in Parts A and B as well as titers of ADA to odronextamab throughout both parts of the study, ending with a conclusive assessment on progression-free survival for all participants."

Answered by AI

How many participants are engaging in this investigation?

"In order to see the study through, Regeneron Pharmaceuticals needs 298 patients that abide by the inclusion criteria. The clinical trial is administered from two centres: Massachusetts General Hospital in New Brunswick and Rutgers Cancer Institute of New jersey in Manhattan."

Answered by AI

Have any iterations of Odronextamab been accepted by the FDA for multiple dosage levels?

"Given the limited clinical data available for Odronextamab, our team has assigned it a value of 1 on a scale from one to three. This Phase One trial will help determine its safety and efficacy profile."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

Odronextamab, a Human CD20×CD3 Bispecific Antibody in Patients with Cd20-positive B-cell Malignancies (ELM-1): Results from the Relapsed or Refractory Non-hodgkin Lymphoma Cohort in a Single-arm, Multicentre, Phase 1 Trial

Bannerji, Rajat, Jon E Arnason, Ranjana H Advani, Jennifer R Brown, John N Allan, Stephen M Ansell, Jeffrey A Barnes, et al.. 2022. “Odronextamab, a Human CD20×CD3 Bispecific Antibody in Patients with Cd20-positive B-cell Malignancies (ELM-1): Results from the Relapsed or Refractory Non-hodgkin Lymphoma Cohort in a Single-arm, Multicentre, Phase 1 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(22)00072-2.

The Lancet HaematologyJournal

Clinical and Translational ScienceJournal

Translational Findings for Odronextamab: From Preclinical Research to a First‐in‐human Study in Patients with CD20+ B‐cell Malignancies

Zhu, Min, Kara Olson, Jessica R. Kirshner, Masood Khaksar Toroghi, Hong Yan, Lauric Haber, Craig Meagher, et al.. 2022. “Translational Findings for Odronextamab: From Preclinical Research to a First‐in‐human Study in Patients with CD20+ B‐cell Malignancies”. Clinical and Translational Science. Wiley. doi:10.1111/cts.13212.

clinicaltrials.govStudy

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

2015. "Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02290951.