Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection – A Phase 2 Pilot Trial - Felzartamab in late ABMR

Medical University of Vienna0 个研究点目标入组 22 人开始时间: 2021年6月23日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•Voluntary written informed consent
•Age >18 years (maximum: 70 years)
•Functioning living or deceased donor allograft after =180 days post-transplantation
•eGFR =20 ml/min/1.73 m2 (CKD-EPI formula)
•HLA class I and/or II antigen-specific antibodies (preformed and/or de novo DSA).
•Active or chronic/active ABMR (±C4d in PTC) according to the Banff 2019 classification
•Molecular ABMR score (MMDx) =0.2
•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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•Patients actively participating in another clinical trial
•Age =18 years
•Female subject is pregnant or lactating or not on adequate contraceptive therapy
•ABO-incompatible transplant
•Index biopsy results:
•T-cell-mediated rejection classified Banff grade =I
•De novo or recurrent severe thrombotic microangiopathy
•Polyoma virus nephropathy
•De novo or recurrent glomerulonephritis
•Acute rejection treatment =3 month before screening
•Previous treatment with other CD38 monoclonal antibodies (e.g. daratumumab)
•Previous treatment with other immunomodulatory monoclonal/polyclonal antibodies (e.g. CD20 Ab rituximab, IL-6/IL-6R Ab) =3 months before study treatment
•Total bilirubin >2×the upper limit of normal [ULN], alanine transaminase and aspartate aminotransferase >2·5×ULN
•Haemoglobin <8 g/dL
•Thrombocytopenia: Platelets <100 G/L
•Leukopenia: Leukocytes <3 G/L
•Neutropenia: Neutrophils < 1.5 G/L
•Hypogammaglobulinemia: Serum IgG <400 mg/dL
•Active viral, bacterial or fungal infection precluding intensified immunosuppression
•Active malignant disease precluding intensified immunosuppressive therapy
•Latent or active tuberculosis (positive QuantiFERON-TB-Gold test)
•Administration of a live vaccine within 6 weeks of screening
•History of alcohol or illicit substance abuse
•Serious medical or psychiatric illness likely to interfere with participation in the study

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