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Monoclonal Antibodies
REGN5837 + Odronextamab for Aggressive B-Cell Lymphoma (ATHENA-1 Trial)
Phase 1
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years
Awards & highlights
ATHENA-1 Trial Summary
This trial is researching if a combination of two experimental drugs is safe and effective for patients with aggressive B-cell non-Hodgkin lymphomas (B-NHLs).
Who is the study for?
This trial is for people with aggressive B-cell non-Hodgkin lymphomas who've had at least two prior treatments, including an anti-CD20 antibody and an alkylating agent. They should be in good physical condition (ECOG 0 or 1) and have proper organ function. Those with certain types of lymphoma, recent other cancer treatments, high-dose steroids, or significant health risks are excluded.Check my eligibility
What is being tested?
The study tests the safety and tolerability of REGN5837 combined with odronextamab in patients whose disease has worsened after previous therapies. It aims to determine the right dose for future studies and assess side effects, drug levels in blood, potential immune responses to the drugs, and their effectiveness against B-NHLs.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to these experimental drugs which could range from mild allergic reactions to more serious complications affecting different organs due to immune overactivity.
ATHENA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab
Incidence of adverse events of special interest (AESIs) of REGN5837 in combination with odronextamab
Incidence of treatment-emergent adverse events (TEAEs) of REGN5837 in combination with odronextamab
+2 moreSecondary outcome measures
Complete response (CR) rate according to the Lugano Classification of response
Concentrations of REGN5837 in the serum
Concentrations of odronextamab in the serum
+8 moreATHENA-1 Trial Design
1Treatment groups
Experimental Treatment
Group I: Odronextamab and REGN5837Experimental Treatment2 Interventions
Odronextamab and REGN5837 will be administered by IV infusion using a step-up dosing schedule.
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Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
622 Previous Clinical Trials
380,640 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
263 Previous Clinical Trials
251,323 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stem cell or organ transplant, nor have I been treated with odronextamab.I have been diagnosed with mantle cell lymphoma.My aggressive B-cell lymphoma has worsened despite two prior treatments including an anti-CD20 antibody and an alkylating agent.I am willing to have a tumor biopsy if it's safe and needed for the study.I am taking more than 10 mg of prednisone or its equivalent daily.I haven't taken any lymphoma medication recently.I will start or have started radiotherapy within 2 weeks before taking the study drug.I do not have any current infections.My cancer is a type of lymphoma that affects the brain.I am fully active or restricted in physically strenuous activity but can do light work.My cancer can be seen and measured on scans.My kidney, liver, and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Odronextamab and REGN5837
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available for this research project?
"Affirmative. Clinicaltrials.gov indicates that this study is in search of patients, first posted on April 12th 2023 and lastly updated on April 27th 2023; 91 individuals are sought at one medical centre."
Answered by AI
How hazardous are Odronextamab and REGN5837 to individuals' health?
"Our research team at Power has ranked the safety of Odronextamab and REGN5837 with a score of 1, as there is currently limited evidence to support their efficacy or protectiveness."
Answered by AI
How many individuals are participating in the clinical trial at present?
"Affirmative. According to the clinicaltrials.gov, this research initiative is actively searching for 91 participants from one medical centre. It was initially posted on April 12th 2023 and recently adjusted on April 27th 2023."
Answered by AI
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