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

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 48 人开始时间: 2020年6月30日最近更新: 2020年11月23日

试验速览

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•1. SAA that is refractory to or has relapsed while on standard of care IST, as defined in the protocol
•2. Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient
•3. Adequate hepatic and renal function as defined in the protocol
•Other protocol-defined inclusion criteria apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•1. Diagnosis of Fanconi anemia as defined in the protocol
•2. Evidence of myelodysplastic syndrome as defined in the protocol
•3. Paroxysmal nocturnal hemoglobinuria (PNH) with evidence of significant hemolysis or history of PNH-associated thrombosis
•4. Treatment with a T cell-depleting agent (eg, ATG or alemtuzumab) within 6 months prior to dosing
•5. Treatment with a calcineurin inhibitor (eg, cyclosporine) within 4 weeks prior to dosing
•6. 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
•7. HIV, hepatitis B or hepatitis C positive by serological testing at the screening visit
•8. Active tuberculosis, latent tuberculosis infection (LTBI) or history incompletely-treated tuberculosis or LTBI
•Other protocol-defined exclusion criteria apply

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