Randomised Controlled Trial Comparing CD62L and CD45RA Depleted Donor Lymphocyte Infusion With T-cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation

Summary

The goal of clinical trial is to compare the efficacy and safety of CD62L depleted donor lymphocyte infusion (DLI) with CD45RA depleted DLI in children who receive T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT). Participants will be randomised to receive either CD62L depleted DLI or CD45RA depleted DLI with HSCT and evaluate for efficacy and safety outcomes.

Timeline

Start

2026-10-02

Primary completion

2029-10-01

Completion

2029-10-01

Publications

• Background Chan WYK, Lee PPW, Cheuk DKL, Chiang AKS, Leung W. A Modified Three-Step Haploidentical Transplantation With TCRalphabeta/CD62L Depletion for Epstein-Barr Virus Hemophagocytic Lymphohistiocytosis and Natural Killer-Cell Lymphoproliferative Disease. Pediatr Blood Cancer. 2025 Aug;72(8):e31818. doi: 10.1002/pbc.31818. Epub 2025 May 20. No abstract available.
• Background Cheuk DKL, Lee PPW, Chan WYK, Chan GCF, So CC, Leung WH. Novel CD62L depleted donor lymphocyte infusion with T-cell receptor alpha-beta depleted haploidentical hematopoietic stem cell transplantation in children. Transpl Immunol. 2025 Mar;89:102176. doi: 10.1016/j.trim.2025.102176. Epub 2025 Jan 30.
• Background Verfuerth S, Sousa PS, Beloki L, Murray M, Peters MD, O'Neill AT, Mackinnon S, Lowdell MW, Chakraverty R, Samuel ER. Generation of memory T cells for adoptive transfer using clinical-grade anti-CD62L magnetic beads. Bone Marrow Transplant. 2015 Oct;50(10):1358-64. doi: 10.1038/bmt.2015.135. Epub 2015 Jun 15.
• Background Zhang J, Barefoot BE, Mo W, Deoliveira D, Son J, Cui X, Ramsburg E, Chen BJ. CD62L- memory T cells enhance T-cell regeneration after allogeneic stem cell transplantation by eliminating host resistance in mice. Blood. 2012 Jun 28;119(26):6344-53. doi: 10.1182/blood-2011-03-342055. Epub 2012 May 17.
• Background Chen BJ, Cui X, Sempowski GD, Liu C, Chao NJ. Transfer of allogeneic CD62L- memory T cells without graft-versus-host disease. Blood. 2004 Feb 15;103(4):1534-41. doi: 10.1182/blood-2003-08-2987. Epub 2003 Oct 9.
• Background Mangare C, Tischer-Zimmermann S, Riese SB, Dragon AC, Prinz I, Blasczyk R, Maecker-Kolhoff B, Eiz-Vesper B. Robust Identification of Suitable T-Cell Subsets for Personalized CMV-Specific T-Cell Immunotherapy Using CD45RA and CD62L Microbeads. Int J Mol Sci. 2019 Mar 20;20(6):1415. doi: 10.3390/ijms20061415.
• Background Triplett BM, Muller B, Kang G, Li Y, Cross SJ, Moen J, Cunningham L, Janssen W, Mamcarz E, Shook DR, Srinivasan A, Choi J, Hayden RT, Leung W. Selective T-cell depletion targeting CD45RA reduces viremia and enhances early T-cell recovery compared with CD3-targeted T-cell depletion. Transpl Infect Dis. 2018 Feb;20(1):10.1111/tid.12823. doi: 10.1111/tid.12823. Epub 2018 Jan 16.
• Background Triplett BM, Shook DR, Eldridge P, Li Y, Kang G, Dallas M, Hartford C, Srinivasan A, Chan WK, Suwannasaen D, Inaba H, Merchant TE, Pui CH, Leung W. Rapid memory T-cell reconstitution recapitulating CD45RA-depleted haploidentical transplant graft content in patients with hematologic malignancies. Bone Marrow Transplant. 2015 Jul;50(7):968-77. doi: 10.1038/bmt.2014.324. Epub 2015 Feb 9.
• Background Shook DR, Triplett BM, Eldridge PW, Kang G, Srinivasan A, Leung W. Haploidentical stem cell transplantation augmented by CD45RA negative lymphocytes provides rapid engraftment and excellent tolerability. Pediatr Blood Cancer. 2015 Apr;62(4):666-73. doi: 10.1002/pbc.25352. Epub 2015 Jan 5.
• Background Bleakley M. Naive T-cell depletion in stem cell transplantation. Blood Adv. 2020 Oct 13;4(19):4980. doi: 10.1182/bloodadvances.2020001888.

Drugs

Indications