Drug intelligence / Profile preview

darTreg

Development stage
Phase 2
Lead developer
University of California, San Francisco
Modality
Regulatory T Cells (Tregs) → Immune Effector Cells → Other Cell Types → Cell Therapies, Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

darTreg refers to autologous donor-alloantigen–reactive regulatory T cells (Tregs) that are expanded ex vivo and infused into transplant recipients. These cells are a form of adoptive cell therapy designed to induce immune tolerance specifically toward the transplanted organ by suppressing alloreactive immune responses while sparing general immunity. The mechanism involves isolating recipient-derived CD4+CD25hiFoxp3+ regulatory T cells that are selectively reactive to donor antigens, expanding them in vitro, and then infusing them back into the patient post-transplantation. The primary indication is for promoting immunological tolerance in solid organ transplantation (notably liver and kidney), with the goal of reducing or eliminating the need for long-term systemic immunosuppression. Clinical studies have shown safety but also highlighted challenges such as loss of function or phenotype after infusion[2][3][4][5].

Other names
donor-alloantigen-reactive regulatory T celldonor alloantigen–reactive Tregdonor-reactive regulatory T cell
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)IL2RA (Interleukin-2 receptor alpha subunit)

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