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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-treatment, approximately 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-treatment, approximately 52 weeks
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 moreSecondary outcome measures
Any clinical response
Changes in hemoglobin cell counts
Changes in lymphocyte cell counts
+17 moreTrial 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
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Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
628 Previous Clinical Trials
382,209 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
266 Previous Clinical Trials
252,279 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had T cell-depleting therapy like ATG or alemtuzumab in the last 6 months.I have been diagnosed with Fanconi anemia or another similar bone marrow failure condition.I have PNH with significant red blood cell breakdown or a history of blood clots due to PNH.My liver and kidney functions are within normal ranges.I cannot or do not want to undergo a stem cell transplant.I have been diagnosed with a bone marrow disorder.My aplastic anemia has returned after immune-suppressive therapy.My SAA hasn't responded to or has returned after standard treatment.I haven't taken calcineurin inhibitors like cyclosporine in the last 4 weeks.I haven't taken eltrombopag, G-CSF, or androgens like danazol in the last 2 weeks.I have or had tuberculosis that was not fully treated.My aplastic anemia has not improved with standard treatment.Please provide more details for an accurate summary.
Research Study Groups:
This trial has the following groups:- Group 1: Part B
- Group 2: Part A
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.
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