Delayed Tolerance Through Mixed Chimerism

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Kidney FailureKidney Transplant; ComplicationsChimera
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.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ossium Health, Inc.

INDUSTRY

collaborator

ITB-Med LLC

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT05900401 - Delayed Tolerance Through Mixed Chimerism | Biotech Hunter | Biotech Hunter