12
Participants
Start Date
May 31, 2025
Primary Completion Date
December 31, 2030
Study Completion Date
December 31, 2030
Combined Kidney/Bone Marrow Transplant
The conditioning regimen to be used in this protocol consists of an ordered series of procedures and treatments including thymic irradiation, low-dose cyclophosphamide, antibody administration (Siplizumab, rituximab and tegoprubart), and bone marrow cell infusion.
Donation of Kidney / Bone Marrow
The donor will undergo nephrectomy and under general anesthesia. Donors will undergo bone marrow harvested under general anesthesia. Sufficient marrow will be obtained to provide at least 2 x 108 nucleated cells per kilogram weight of the recipient.
Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart)
Recipients will receive a conditioning regimen that includes rituximab on study day -6 and -2, Siplizumab (0.6mg/kg) on day -6, -1, 0 and +1, cyclophosphamide (CP, 22.5mg/kg) on days -5 and -4. Tegoprubart (Fc-modified anti-CD154 mAB, Eledon Pharm) 20mg/kg will be administered on days 0, 2, 5, 12 and 19).
RECRUITING
Massachusetts General Hospital, Boston
Collaborators (1)
Eledon Pharmaceuticals
INDUSTRY
ITB-Med LLC
INDUSTRY
Tatsuo Kawai, MD, PhD
OTHER