Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous immunoglobulins for AMR after lung transplantation and elucidate important clinical and immunologic phenotypes and mechanisms associated with these outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: John F. McDyer, MD
• Treatments: Antibodies; Immunoglobulins; Proteasome Inhibitors

Criteria

Inclusion Criteria:

• Adult lung transplant recipients ≥ 18 years of age who meet the diagnostic criteria for AMR and who have underwent PFT testing unless intubated and transbronchial biopsy prior to enrollment.

Exclusion Criteria:

• Direct contraindications or previous intolerances to any component of the standard of care regimen including PLEX, 5% human albumin, 5% gammagard S/D or 10% gammagard liquid

• Leukopenia

• Neutropenia

• Thrombocytopenia

• Known Child-Pugh B/C cirrhosis

• Total bilirubin > 4

• ALT > 90

• Known systolic heart failure with LVEF < 40%

• Known pulmonary hypertension

• Any uncontrolled comorbid condition

• Pregnant women

• Breastfeeding women

• Ongoing bacterial or fungal or viral infection that is life-threatening

• Active cytomegalovirus disease

• Active varicella zoster infection

• Previous intolerance to carfilzomib

• Concurrent use of another proteasome inhibitor (e.g., bortezomib)