drugset / Trial / NCT01660607
Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell
Phase 1/2
Completed
68 enrolled
Stanford University
National Heart, Lung, and Blood Institute (NHLBI) · collabNational Institutes of Health (NIH) · collab
Non-randomizedSequentialOpen-labelTreatment
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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Conventional T-Cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Conventional T-Cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | Regulatory T cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Regulatory T cells | Cell therapy | 3e+06 cells/kg | — |
| Background | CD34+ Hematopoietic Progenitor Cells | Cell therapy | — | — |