Health TrialsbyHealthPanel

Delayed Tolerance Through Mixed Chimerism

ConditionsKidney FailureKidney Transplant; ComplicationsChimera
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMassachusetts General Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Kidney transplant recipients from either LD or DD, with cryo-preserved HSCs available, good renal function (GFR>60 ml/min/1.73m2), normal current allograft biopsy, and no history of documented rejection episodes.

First or second renal transplant.

Use of FDA-approved methods of contraception (those with less than a 3% failure rate) by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation. (For further information on FDA- approved methods of contraception, see https://www.fda.gov/media/150299/download

Ability to understand and provide informed consent.

Disqualifiers

ABO blood group-incompatible renal allograft.

Evidence of anti-HLA antibody (donor specific with an MFI >1000) as assessed by routine methodology (Luminex)

Previous history of biopsy proven rejection.

Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (<100,000/mm3).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone Marrow Transplant

    Other intervention

    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/Surgery

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Kidney and Stem Cell RecipientsExperimental treatment 5 interventions
Group B: Kidney and Stem Cell DonorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of transient mixed chimerism

Time frame
3 months
2

Incidence of renal allograft tolerance

Time frame
2 years after immunosuppression withdrawal

Secondary outcomes

1

Incidence of Participant Survival

Time frame
2 years after immunosuppression withdrawal
2

Incidence of Graft Survival

Time frame
2 years after immunosuppression withdrawal
3

Incidence of Chimeric Transition Syndrome

Time frame
3 months
4

Incidence of Allograft Rejection

Measuring incidence of acute or chronic rejection free survival

Time frame
2 years after immunosuppression withdrawal

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Ossium Health, Inc.

Collaborator

ITB-Med LLC

Collaborator

Source ClinicalTrials.gov
Apply now