Drug intelligence / Profile preview

donor-derived mesenchymal stromal cells + alemtuzumab + belatacept + sirolimus

Development stage
Unknown
Lead developer
Immune Tolerance Network
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Small Molecules, Stem Cell Therapies → Cell Therapies, Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Oral
01

Overview

This investigational combination therapy, developed by the **National Institute of Allergy and Infectious Diseases (NIAID)** and the **Immune Tolerance Network (ITN)**, utilizes donor-derived mesenchymal stromal cells (MSCs) in conjunction with a specific immunosuppressive regimen to induce operational tolerance in kidney transplant recipients. The regimen includes induction with **alemtuzumab** (a CD52-directed cytolytic antibody), followed by maintenance with **belatacept** (a selective T-cell costimulation blocker) and **sirolimus** (an mTOR inhibitor). The donor-derived MSCs are multipotent bone marrow cells propagated ex vivo, intended to modulate the recipient's immune response—specifically targeting T cells, B cells, and dendritic cells—to facilitate the withdrawal of long-term immunosuppression. The therapy was evaluated in the Phase 1 **TEACH** (Tolerance by Engaging Antigen During Cellular Homeostasis) trial, which was ultimately terminated after failing to establish chimerism or induce tolerance.

Other names
TEACH trial regimenDonor-derived MSCsDonor-derived mesenchymal stromal cells
02

Targets

CD80 (T-lymphocyte activation antigen CD80)CD86 (T-lymphocyte activation antigen CD86)mTOR (Mammalian target of rapamycin kinase)CD52 (CD52 Antigen)

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