drugset / Trial / NCT06972069
Tolerance Through Mixed Chimerism (Sip-Tego)
Phase 0
Active not recruiting
12 enrolled
Tatsuo Kawai, MD, PhD
Eledon Pharmaceuticals · collabITB-Med LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.
Timeline
- Start
- 2025-05-31
- Primary completion
- 2030-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | — | — |
| Subject | Cyclophosphamide | Other / unclassified | 22.5 mg/kg | — |
| Subject | MEDI-507 | Monoclonal antibody | 0.6 mg/kg | — |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Subject | Tegoprubart | Monoclonal antibody | 20 mg/kg | — |