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 - R7257-RAA-1947

Regeneron Pharmaceuticals Inc.0 个研究点目标入组 33 人开始时间: 2024年5月1日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Part A: SAA that is IST-refractory or IST-relapsed, as defined in the protocol, Part B: SAA that is IST-relapsed, as defined in the protocol, Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient, Adequate hepatic and renal function as defined in the protocol, Other protocol-defined inclusion criteria apply

•Diagnosis of Fanconi anemia or other congenital bone marrow failure syndrome as defined in the protocol, Other protocol-defined exclusion criteria apply, Evidence of myelodysplastic syndrome as defined in the protocol, Paroxysmal nocturnal hemoglobinuria (PNH) with evidence of clinically significant hemolysis (eg, treatment indicated) or history of PNH-associated thrombosis, Treatment with a T cell-depleting agent (eg, ATG or alemtuzumab) within 6 months prior to dosing, Treatment with a calcineurin inhibitor (eg, cyclosporine) within 4 weeks prior to dosing for patients enrolled in Part A, Treatment with eltrombopag or investigational thrombopoietin receptor agonist, Granulocyte Colony-Stimulating Factor (G-CSF), or an androgen (eg, danazol), within 2 weeks prior to dosing, HIV, hepatitis B or hepatitis C positive by serological testing at the screening visit as defined in the protocol, Active tuberculosis, latent tuberculosis infection (LTBI) or history incompletely-treated tuberculosis or LTBI, Active infection as defined in the protocol

发起方

Regeneron Pharmaceuticals Inc.