REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy
Status:
Recruiting
Trial end date:
2024-08-08
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the safety and tolerability of REGN7257 in
patients with severe aplastic anemia (SAA) that is refractory to or has relapsed while on
standard of care immunosuppressive therapy (IST). An additional primary objective (for Part B
only) is to evaluate the clinical efficacy of REGN7257 in IST-refractory/relapsed patients.
The secondary objectives of this study are to assess the following for REGN7257:
- Clinical response over time
- Maintenance of response
- Impact on transfusion requirements
- Effect on blood counts and cell populations
- Pharmacokinetics (PK)
- Immunogenicity