Phase 2
Completed N=22
Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation
Lung Transplant Rejection
Source: ClinicalTrials.gov NCT02474927 ↗
Enrolled (actual)
22
Serious AEs
18.2%
Results posted
Apr 2022
Primary outcomePrimary: Number of Participants With a Decrease in Titer of One or More DSA (Either Reduced MFI or Absence of DSA on Same Dilution) — 17 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease in Titer of One or More DSA (Either Reduced MFI or Absence of DSA on Same Dilution) |
17 | — |
| PRIMARY Number of Participants With a Decrease in DSA Titer |
10 | — |
| PRIMARY Number of Participants With an Absence of One or More Previously Positive DSA on Cq1 Assay |
6 | — |
| SECONDARY Number of Participants With a Decrease in Titer of One or More DSA (Either Reduced MFI or Absence of DSA on Same Dilution) |
17 | — |
| SECONDARY Number of Participants With a Decrease in DSA Titer |
10 | — |
| SECONDARY Number of Participants With an Absence of One or More Previously Positive DSA on Cq1 Assay |
6 | — |
| SECONDARY Absolute Change in Forced Expiratory Volume in 1 Second (FEV1) |
1.77; 2.09 | 0.16 |
| SECONDARY Presence or Absence of Pathologic Changes Consistent With AMR on Transbronchial Biopsy |
— | — |
| SECONDARY Patient Death Attributable to AMR |
1 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02474927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.