Tolerance Through Mixed Chimerism (Sip-Tego)

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Kidney FailureTransplant Recipient (Kidney)Transplant ToleranceImmunosuppresionImmunosuppression 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).

Trial Locations (1)

02114

RECRUITING

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Eledon Pharmaceuticals

INDUSTRY

collaborator

ITB-Med LLC

INDUSTRY

lead

Tatsuo Kawai, MD, PhD

OTHER