Delayed Tolerance Through Mixed Chimerism

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05900401
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Chimera
  • Kidney Failure
  • Kidney Transplant; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Transplant — OTHER
    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 — PROCEDURE
    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 — DRUG
    Fludarabine 15 mg/m2/day on days -5 to -3 (3 doses)
  • Cyclophosphamide — DRUG
    Cyclophosphamide (CP) 30 mg/kg/day on days -5 and -4
  • Rituximab — DRUG
    Rituximab on study day -6
  • Siplizumab — DRUG
    Siplizumab (anti-CD2 mAb) on days, -2, -1, 0 and +1.

Study Details

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 Dates

Start date
Oct 1, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Kidney and Stem Cell Recipients
    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)
  • Experimental: Kidney and Stem Cell Donors
    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

Primary Outcome Measure

Incidence of transient mixed chimerism [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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