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A Phase 1/2 Study of REGN7257 (Anti-Interleukin 2 Receptor Subunit Gamma [IL2RG] Monoclonal Antibody) in Patients with Severe Aplastic Anemia that is Refractory to or Relapsed on Immunosuppressive Therapy

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508601-24-00
Acronym
R7257-RAA-1947
Enrollment
14
Registered
2024-06-14
Start date
2021-09-13
Completion date
2025-06-16
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe aplastic anemia (SAA)

Brief summary

Part A: Incidence of adverse events (AEs), incidence of serious adverse events (SAEs), and incidence and severity of treatment-emergent adverse events (TEAEs);, Part B: Incidence of serious adverse events (SAEs), incidence and severity of treatment-emergent adverse events (TEAEs);, Part B: Overall response rate (ORR);

Detailed description

Overall response rate (ORR); Parts A & B, Complete response (CR); Parts A and B, Partial response (PR); Parts A and B, Time to best response; Part A, Time to best response; Part B, Time to first response; Part A, Time to first response; Part B, Any clinical response; Part A, Any clinical response; Part B, Platelet transfusions per month over time; Part A, Platelet transfusions per month over time; Part B, Red blood cell transfusions per month over time; Part A, Red blood cell transfusions per month over time; Part B, Changes in lymphocyte cell counts; Part A, Changes in lymphocyte cell counts; Part B, Changes in neutrophil cell counts; Part A, Changes in neutrophil cell counts; Part B, Changes in hemoglobin cell counts; Part A, Changes in hemoglobin cell counts; Part B, Changes in reticulocyte cell counts; Part A, Changes in reticulocyte cell counts; Part B, Changes in platelet cell counts; Part A, Changes in platelet cell counts; Part B, Changes in the whole blood immune cell subsets (T cells); Part A, Changes in the whole blood immune cell subsets (T cells); Part B, Changes in the whole blood immune cell subsets (B cells); Part A, Changes in the whole blood immune cell subsets (B cells); Part B, Changes in the whole blood immune cell subsets [Natural killer (NK) cells]; Part A, Changes in the whole blood immune cell subsets (NK cells); Part B, Drug concentrations in serum over time; Part A, Drug concentrations in serum over time; Part B, Incidence of treatment-emergent anti-drug antibody (ADA) over time; Part A, Incidence of treatment-emergent ADA over time; Part B

Interventions

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A: Incidence of adverse events (AEs), incidence of serious adverse events (SAEs), and incidence and severity of treatment-emergent adverse events (TEAEs);, Part B: Incidence of serious adverse events (SAEs), incidence and severity of treatment-emergent adverse events (TEAEs);, Part B: Overall response rate (ORR);

Secondary

MeasureTime frame
Overall response rate (ORR); Parts A & B, Complete response (CR); Parts A and B, Partial response (PR); Parts A and B, Time to best response; Part A, Time to best response; Part B, Time to first response; Part A, Time to first response; Part B, Any clinical response; Part A, Any clinical response; Part B, Platelet transfusions per month over time; Part A, Platelet transfusions per month over time; Part B, Red blood cell transfusions per month over time; Part A, Red blood cell transfusions per month over time; Part B, Changes in lymphocyte cell counts; Part A, Changes in lymphocyte cell counts; Part B, Changes in neutrophil cell counts; Part A, Changes in neutrophil cell counts; Part B, Changes in hemoglobin cell counts; Part A, Changes in hemoglobin cell counts; Part B, Changes in reticulocyte cell counts; Part A, Changes in reticulocyte cell counts; Part B, Changes in platelet cell counts; Part A, Changes in platelet cell counts; Part B, Changes in the whole blood

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026