drugset / Trial / NCT03504241
Tolerance by Engaging Antigen During Cellular Homeostasis
Phase 1
Completed
8 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collabPPD Development, LP · collabRho Federal Systems Division, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine if: * it is safe to give mesenchymal stromal cells (MSCs) to kidney transplant recipients, and * the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop all anti-rejection drugs, without rejection of their kidney (renal) allograft, a process called "immunosuppression withdrawal".
Timeline
- Start
- 2018-07-30
- Primary completion
- 2023-09-06
- Completion
- 2025-09-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | Belatacept | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | Donor-derived Mesenchymal Stromal Cells | Cell therapy | 10000 cells/kg | — |
| Subject | Donor-derived Mesenchymal Stromal Cells | Cell therapy | 100000 cells/kg | — |
| Subject | Sirolimus | Small molecule | 2 mg | Oral |
| Background | Alemtuzumab | Monoclonal antibody | 30 mg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Mycophenolate acid | Unknown | — | — |
| Background | Prednisone | Other / unclassified | — | — |