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Monoclonal Antibodies

REGN7257 for Severe Aplastic Anemia

Phase 1 & 2
Recruiting
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient
Part A: SAA that is IST-refractory or IST-relapsed, as defined in the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-treatment, approximately 52 weeks
Awards & highlights

Study Summary

This trial is assessing the safety and efficacy of REGN7257 in patients with severe aplastic anemia who are refractory or have relapsed after immunosuppressive therapy.

Who is the study for?
This trial is for adults with severe aplastic anemia who haven't improved or have relapsed after immunosuppressive therapy. They can't be candidates for stem cell transplant, either because it's not suitable or they've refused it. Participants need to have good liver and kidney function.Check my eligibility
What is being tested?
The study tests REGN7257's safety and how well patients tolerate it. For part of the study, they'll also check if the drug effectively treats severe aplastic anemia by observing clinical responses, changes in transfusion needs, blood counts, and immune reactions over time.See study design
What are the potential side effects?
While specific side effects of REGN7257 are not listed here, common ones may include reactions at the injection site, fatigue, headache, nausea and potential impacts on liver enzymes which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I cannot or do not want to undergo a stem cell transplant.
Select...
My SAA hasn't responded to or has returned after standard treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-treatment, approximately 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-treatment, approximately 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
+1 more
Secondary outcome measures
Any clinical response
Changes in hemoglobin cell counts
Changes in lymphocyte cell counts
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 Intervention
Part B: Multiple REGN7257 dosages.
Group II: Part AExperimental Treatment1 Intervention
Part A: Single ascending dose (SAD) escalation cohorts

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
616 Previous Clinical Trials
379,812 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
260 Previous Clinical Trials
251,009 Total Patients Enrolled

Media Library

REGN7257 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04409080 — Phase 1 & 2
Aplastic Anemia Research Study Groups: Part A, Part B
Aplastic Anemia Clinical Trial 2023: REGN7257 Highlights & Side Effects. Trial Name: NCT04409080 — Phase 1 & 2
REGN7257 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04409080 — Phase 1 & 2

Frequently Asked Questions

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

What can be expected to be gleaned from the findings of this clinical experiment?

"This medical study will evaluate the incidence of serious adverse events over a 12-month period; additional metrics being monitored include complete response (A & B), partial response (A & B) and the proportion of patients who maintain any clinical responses."

Answered by AI

What is the status of enrolment for this research trial?

"Per clinicaltrials.gov, this trial is currently open to volunteers, with the original posting on January 13th 2021 and most recently updated September 26th 2022."

Answered by AI

What is the ceiling of participants for this trial?

"Affirmative. Data on clinicaltrials.gov confirms that applications for this medical trial, which was initially posted on January 13th 2021, are currently being accepted. A total of 57 patients have to be enrolled from 3 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Cleveland Clinic Foundation
The University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have been on cyclosporine and revolad for 2 and half months with poor results.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy
2021. "REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04409080.
All > Aplastic Anemia
~11 spots leftby Jan 2026
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