FDA Approves Treg Cell Therapy - Summary - MDSpire
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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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Objective:

To improve chronic graft-versus-host disease-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation.

Approach:
  • Therapy Description: Tregzi is a donor-derived cellular immunotherapy composed of purified hematopoietic stem and progenitor cells, regulatory T cells, and conventional T cells collected from an 8/8 human leukocyte antigen-matched donor.
  • Clinical Trial: The approval was based on the PRECISION-T trial, which enrolled 187 adult patients with blood cancers, comparing Tregzi to standard stem cell transplant.
Key Findings:
  • One-year chronic GVHD-free survival was 78% with Tregzi compared to 38% with a standard transplant.
  • Serious chronic GVHD occurred within 1 year in 13% of patients treated with Tregzi versus 44% in the standard transplant group.
  • The most common side effects were infections; no severe infusion reactions or graft failures were reported.
Interpretation:

Regulatory T cells help regulate immune responses and maintain immune tolerance, aiming to reduce chronic GVHD risk during immune system reconstitution.

Limitations:
  • The study's primary endpoint was chronic GVHD-free survival measured over 2 years.
  • The trial involved a specific patient population with blood cancers.
Conclusion:

Tregzi represents a significant advancement in the treatment of chronic graft-versus-host disease in patients undergoing stem cell transplantation.

Sources:

Original Source(s)

FDA Approves Treg Cell Therapy

  • by Kathryn Wighton

  • July 1, 2026

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