drugset / Trial / NCT04540380

Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH

NCT04540380

Phase 1 Active not recruiting 20 enrolled Massachusetts General Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal is to investigate the safety of the conditioning regimen, and its ability to induce donor/recipient lymphohematopoietic chimerism without Chimerism Transition Syndrome (CTS), which may result in donor-specific unresponsiveness (tolerance) to the renal allograft in the absence of maintenance immunosuppression.

Timeline

Start
2021-09-01
Primary completion
2027-01
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified 22.5 mg/kg
Background Fludarabine Small molecule 10 mg/m2
Background Rituximab Monoclonal antibody
Background Siplizumab Monoclonal antibody

Indications