EUCTR2021-000545-40-DEActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
- •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
Investigators
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