Phase 2 N=22 Treatment

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

Lung Transplant Rejection

Bottom Line

View on ClinicalTrials.gov: NCT02474927 ↗

Enrolled (actual)

Serious AEs

18.2%

Results posted

Apr 2022

Primary outcome: 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 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Carfilzomib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: John F. McDyer, MD
Primary completion: Nov 2020

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 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	—

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.

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)

View full record on ClinicalTrials.gov →

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.