Siltuximab for Rejection

(Siltux-AMR Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Washington University School of Medicine

Must be taking: Carfilzomib, Anti-thymocyte globulin

Must not be taking: IL-6 blockers

Disqualifiers: Pregnancy, Lymphoma, Cancer, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Antibody-mediated rejection after lung transplantation commonly results in allograft failure and death in spite of current therapeutic regimens. We are testing the safety and tolerability of the addition of a novel immunosuppressive medication to routine treatment for antibody-mediated rejection. Future studies will be needed to assess efficacy if this study demonstrates safety

Eligibility Criteria

This trial is for individuals who have undergone lung transplantation and are now experiencing antibody-mediated rejection. Participants should be stable enough to receive additional treatment on top of their routine immunosuppression.

Inclusion Criteria

I have high levels of specific antibodies against transplant markers.

I have a new diagnosis of antibody-mediated rejection and will be treated with Carfilzomib or anti-thymocyte globulin.

I am 18 years old or older.

Exclusion Criteria

I have had diverticulitis before.

I am scheduled for surgery (not including bronchoscopy) within the next 4 months.

Pregnant or breast feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Siltuximab or placebo intravenously on Days 1 and 22

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Siltuximab

Trial Overview The study is testing the safety and tolerability of Siltuximab, a new immunosuppressive medication, when added to standard treatments for post-lung transplant rejection. It's an early-stage trial comparing Siltuximab with a placebo.

Participant Groups

Group I: Siltuximab half-dose (5.5mg/kg) IV Experimental Treatment 1 Intervention

Siltuximab 5.5 mg/kg IV on Days 1 and 22

Group II: Siltuximab full-dose (11mg/kg) IV Experimental Treatment 1 Intervention

Siltuximab 11mg/kg IV on Days 1 and 22

Group III: Placebo IV Placebo Group 1 Intervention

Placebo IV on Days 1 and 22

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+