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REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

NCT04409080 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-10-24

No results posted yet for this study

Summary

This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in an impairment of the production of blood cells.

The main purpose of this two-part study (Part A and Part B) is to test how safe and tolerable REGN7257 is in patients with SAA in which other Immunosuppressive therapies (ISTs) have not worked well.

The study is looking at several other research questions to better understand the following properties of REGN7257:

* Side effects that may be experienced by participants taking REGN7257
* How REGN7257 works in the body
* How much REGN7257 is present in blood after dosing
* If REGN7257 works to raise levels of certain blood counts after treatment
* How quickly REGN7257 works to raise levels of certain blood counts
* In patients for whom REGN7257 works to raise levels of certain blood counts after treatment, how many continue to show such a response throughout the study
* If REGN7257 works to lower the number of platelet and red blood cell transfusions needed
* How REGN7257 changes immune cell counts and composition
* How the body reacts to REGN7257 and if it produces proteins that bind to REGN7257 (this would be called the formation of anti-drug antibodies \[ADA\])

Conditions

  • Severe Aplastic Anemia (SAA)

Interventions

DRUG

REGN7257

Administered by intravenous (IV) infusion, in Part A and B.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2024-10-17
Completion
2024-10-17
FDA Drug
Yes

Countries

  • United States
  • France
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04409080 on ClinicalTrials.gov