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Delayed Tolerance Through Mixed Chimerism
Sponsor: Massachusetts General Hospital
Summary
This study will examine the safety and effectiveness of a bone marrow transplant after kidney transplant (from either a living or deceased donor). An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-10-01
Completion Date
2030-12
Last Updated
2025-12-09
Healthy Volunteers
No
Interventions
Bone Marrow Transplant
Months-Years after standard transplant, patients will undergo bone marrow transplant (either from prospective collection of stem cells from their living donor, or from bone marrow collected at the time of deceased donation)
Peripheral Blood Stem Cell Collection
PBSC will be collected from the LD via leukapheresis 1-4 weeks before the scheduled HSCT. The donor will first undergo standard GCSF mobilization: GCSF (can be TBO-GCSF) dosed at 10 mcg/kg/d (rounded to nearest pre-filled syringe) administered subcutaneously daily for 5 consecutive days. On the 5th day, the donor will undergo standard large volume leukapheresis. The target yield will be 2-3 x 106 CD34+ cells / kg of actual recipient body weight. A maximum of 3 days of pheresis will be allowed. A minimum of 2 x 106 CD34+ cells / kg of actual recipient body weight will be required to proceed.
Fludarabine
Fludarabine 15 mg/m2/day on days -5 to -3 (3 doses)
Cyclophosphamide
Cyclophosphamide (CP) 30 mg/kg/day on days -5 and -4
Rituximab
Rituximab on study day -6
Siplizumab
Siplizumab (anti-CD2 mAb) on days, -2, -1, 0 and +1.
Locations (1)
Massachusetts General Hospital
Boston, Massachusetts, United States