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ACTIVE NOT RECRUITING
NCT05900401
PHASE1/PHASE2

Delayed Tolerance Through Mixed Chimerism

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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

OTHER

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)

PROCEDURE

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.

DRUG

Fludarabine

Fludarabine 15 mg/m2/day on days -5 to -3 (3 doses)

DRUG

Cyclophosphamide

Cyclophosphamide (CP) 30 mg/kg/day on days -5 and -4

DRUG

Rituximab

Rituximab on study day -6

DRUG

Siplizumab

Siplizumab (anti-CD2 mAb) on days, -2, -1, 0 and +1.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States