Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

Summary

This study looks at giving specific types of immune cells, called regulatory T cells and conventional T cells, to patients with blood cancers who are receiving a stem cell transplant. These cells are added back to help the immune system recover and reduce complications after the transplant.

Timeline

Start

2012-02-09

Primary completion

2023-12-20

Completion

2023-12-20

Outcome

Met primary endpoint

paper The primary end point of significantly improved 1-year GRFS was achieved at 64% evaluated against a predicted incidence of 40% (P = .002) PMID 39792934 ↗

Publications

• Meyer EH, Pavlova A, Villar-Prados A, Bader C, Xie B, Muffly L, Kim P, Sutherland K, Bharadwaj S, Dahiya S, Frank M, Arai S, Johnston L, Miklos D, Rezvani A, Shiraz P, Sidana S, Shizuru J, Weng WK, Agrawal V, Putnam A, Fernhoff N, Tamarisis J, Lu Y, Pawar RD, McClellan JS, Lowsky R, Negrin RS. Donor regulatory T-cell therapy to prevent graft-versus-host disease. Blood. 2025 May 1;145(18):2012-2024. doi: 10.1182/blood.2024026446.
• Bader CS, Pavlova A, Lowsky R, Muffly LS, Shiraz P, Arai S, Johnston LJ, Rezvani AR, Weng WK, Miklos DB, Frank MJ, Tamaresis JS, Agrawal V, Bharadwaj S, Sidana S, Shizuru JA, Fernhoff NB, Putnam A, Killian S, Xie BJ, Negrin RS, Meyer EH. Single-center randomized trial of T-reg graft alone vs T-reg graft plus tacrolimus for the prevention of acute GVHD. Blood Adv. 2024 Mar 12;8(5):1105-1115. doi: 10.1182/bloodadvances.2023011625.
• Meyer EH, Laport G, Xie BJ, MacDonald K, Heydari K, Sahaf B, Tang SW, Baker J, Armstrong R, Tate K, Tadisco C, Arai S, Johnston L, Lowsky R, Muffly L, Rezvani AR, Shizuru J, Weng WK, Sheehan K, Miklos D, Negrin RS. Transplantation of donor grafts with defined ratio of conventional and regulatory T cells in HLA-matched recipients. JCI Insight. 2019 May 16;4(10):e127244. doi: 10.1172/jci.insight.127244. eCollection 2019 May 16.

Drugs

Indications