Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT06972069

Tolerance Through Mixed Chimerism (Sip-Tego)

Led by Tatsuo Kawai, MD, PhD · Updated on 2025-09-25

12

Participants Needed

1

Research Sites

291 weeks

Total Duration

On this page

Sponsors

T

Tatsuo Kawai, MD, PhD

Lead Sponsor

E

Eledon Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tolerance Through Mixed Chimerism (Sip-Tego)

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 18-65 years of age
  • Chronic kidney disease stage V (GFR <15 ml/min/1.73m2) or end-stage renal disease treated or about to be treated with hemodialysis or peritoneal dialysis
  • Candidate for a living-donor kidney transplant from an HLA matched or mismatched donor
  • First or second kidney transplant
  • Epstein-Barr virus (EBV) seropositive
  • Use of FDA-approved contraception from treatment start until 24 months after transplant
  • Ability to understand and provide informed consent
  • Negative COVID-19 test during screening and two days prior to procedure
Not Eligible

You will not qualify if you...

  • ABO blood group-incompatible kidney transplant
  • Presence of donor-specific antibody within 6 months before transplant
  • Persistent low white blood cell count (less than 2,000/mm3) or low platelet count (less than 100,000/mm3)
  • Positive for HIV-1, hepatitis B core antigen, hepatitis C virus RNA, or hepatitis B surface antigen
  • Untreated infections
  • Left ventricular ejection fraction less than 40% or clinical heart failure
  • Forced expiratory volume or diffusing capacity less than 50% of predicted
  • Pregnant or breastfeeding women
  • Active cancer or high risk of cancer recurrence
  • Kidney disease with high risk of recurrence in transplant
  • Prior dose-limiting radiation therapy for cancer
  • Genetic diseases or family history increasing radiation sensitivity or physical deformities preventing proper irradiation
  • Enrollment in other investigational drug studies within 30 days before enrollment
  • Abnormal liver function tests or coagulation studies or on chronic anticoagulation
  • Allergy or sensitivity to study drugs (cyclophosphamide, tacrolimus, siplizumab, tegoprubart, rituximab)
  • Any medical condition deemed incompatible by investigator, including alcohol or drug abuse
  • Chronic or intermittent use of immunosuppressant medications
  • Poorly controlled non-insulin dependent diabetes (HbA1c ≥8%) or severe diabetes complications affecting daily activities

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

K

Kerry Augusta, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Tolerance Through Mixed Chimerism (Sip-Tego) | DecenTrialz