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Tolerance Through Mixed Chimerism (Sip-Tego)

NCT06972069 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-25

No results posted yet for this study

Summary

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

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

Interventions

PROCEDURE

Combined Kidney/Bone Marrow Transplant

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, rituximab and tegoprubart), and bone marrow cell infusion.

PROCEDURE

Donation of Kidney / Bone Marrow

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.

DRUG

Conditioning Regimen (Rituxan, Siplizumab, Cyclophosphamide, Tegoprubart)

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, 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).

Sponsors & Collaborators

  • Eledon Pharmaceuticals

    collaborator INDUSTRY

  • ITB-Med LLC

    collaborator INDUSTRY

  • Tatsuo Kawai, MD, PhD

    lead OTHER

Principal Investigators

  • Tatsuo Kawai, MD PhD · Principal Investigator / Transplant Surgeon

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06972069 on ClinicalTrials.gov