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
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- STATUS
- Recruiting
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- End date
- Aug 8, 2024
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- participants needed
- 57
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- sponsor
- Regeneron Pharmaceuticals
Summary
The primary objective of this study is to assess the safety and tolerability of REGN7257 in patients with immunosuppressive therapy (IST)-refractory or IST-relapsed severe aplastic anemia (SAA). An additional primary objective (for Part B only) is to evaluate the clinical efficacy of REGN7257 in patients with IST-refractory or IST-relapsed SAA.
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
Details
| Condition | Severe Aplastic Anemia (SAA) |
|---|---|
| Treatment | REGN7257 |
| Clinical Study Identifier | NCT04409080 |
| Sponsor | Regeneron Pharmaceuticals |
| Last Modified on | 16 October 2022 |
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