FDA Approves Treg Cell Therapy - Takeaways - MDSpire

FDA Approves Treg Cell Therapy

A randomized clinical trial found higher chronic GVHD-free survival and lower rates of serious chronic GVHD compared with standard transplantation in adults with blood cancers.

  • By

  • Kathryn Wighton

  • July 1, 2026

  • 2 min

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  • 1

    The FDA approved Tregzi, the first regulatory T-cell-based immunotherapy for chronic graft-versus-host disease in blood cancer patients.

  • 2

    Tregzi is composed of donor-derived regulatory T cells and conventional T cells from an 8/8 HLA-matched donor.

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    The approval was based on the PRECISION-T trial, which included 187 adult patients with blood cancers.

  • 4

    One-year chronic GVHD-free survival was 78% with Tregzi, compared to 38% with standard stem cell transplant.

  • 5

    The most common side effects of Tregzi were infections, with no severe infusion reactions reported during the study.

Original Source(s)

FDA Approves Treg Cell Therapy

  • by Kathryn Wighton

  • July 1, 2026

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