Tolerance Through Mixed Chimerism (Sip-Tego)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Tatsuo Kawai, MD, PhD
Study ID
NCT06972069
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Immunosuppresion
  • Immunosuppression After Kidney Transplantation
  • Kidney Failure
  • Transplant Recipient (Kidney)
  • Transplant Tolerance

Eligibility Criteria

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

Interventions

  • Combined Kidney/Bone Marrow Transplant — PROCEDURE
    The conditioning regimen to be used in this protocol consists of an ordered series of procedures and treatments including thymic irradiation, low-dose cyclophosphamide, antibody administration (Siplizumab (or ATGAM), rituximab and tegoprubart), and bone marrow cell infusion.
  • Donation of Kidney / Bone Marrow — PROCEDURE
    The donor will undergo nephrectomy and under general anesthesia. Donors will undergo bone marrow harvested under general anesthesia. Sufficient marrow will be obtained to provide at least 2 x 108 nucleated cells per kilogram weight of the recipient.
  • Conditioning Regimen (Rituxan, Siplizumab (or ATGAM), Cyclophosphamide, Tegoprubart) — DRUG
    Recipients will receive a conditioning regimen that includes rituximab on study day -6 and -2, Siplizumab (0.6mg/kg) on day -6, -1, 0 and +1 (or ATGAM if Siplizumab becomes unavailable), cyclophosphamide (CP, 22.5mg/kg) on days -5 and -4. Tegoprubart (Fc-modified anti-CD154 mAB, Eledon Pharm) 20mg/kg will be administered on days 0, 2, 5, 12 and 19).

Study Details

This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.

Key Dates

Start date
May 31, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

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

Arms

  • Experimental: Recipient
    Recipient of kidney and bone marrow transplant
  • Other: Donor
    Living donors of kidney and bone marrow transplant

Primary Outcome Measure

Induction of mixed chimerism without chimeric transition syndrome [ Time Frame: 7 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Kerry Augusta, RN
[email protected]
617-724-8570
Tatsuo Kawai, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA

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