A new marrow T cell depletion method using anti-CD6 monoclonal antibody-conjugated magnetic beads and its clinical application for prevention of acute graft-vs.-host disease in allogeneic bone marrow transplantation: results of a phase I-II trial

Int J Hematol. 1999 Jan;69(1):27-35.

Abstract

We established a simple method of T cell depletion using anti-CD6 monoclonal antibody-conjugated immunomagnetic beads. Preliminary experiments using this method demonstrated that CD3+ T cells could be partially depleted without depleting CD56+ NK cells. A phase I-II clinical study was performed to assess the safety and efficacy of this partial T cell depletion method for the prevention of acute graft-vs.-host disease (GVHD) in 10 leukemia patients at high risk for GVHD (defined as 1) unrelated transplant from MLC-positive or HLA-DRB1 mismatched donor or 2) related transplant from serologically HLA-A, -B, or -DR one-locus mismatched donor). Cyclosporine (CSP) and methotrexate (MTX) were used for additional prophylaxis against GVHD in all cases. Sustained engraftment occurred in 9 of the 10 patients. Although acute GVHD developed in 6 of the 9 evaluable patients, none developed more than grade III severe acute GVHD. Five patients were alive in remission at a median follow-up of 32 months after bone marrow transplantation, and no relapse of leukemia was observed. We conclude from this pilot study that selective T cell depletion with anti-CD6 monoclonal antibody coupled with CSP and MTX posttransplant immunosuppressive therapy is safe. Further analysis of the phase II-III study is needed to confirm the effectiveness of this protocol.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adenoviridae Infections / etiology
  • Adult
  • Antibodies, Monoclonal / immunology*
  • Antigens, CD / immunology*
  • Antigens, Differentiation, T-Lymphocyte / immunology*
  • Antiviral Agents / therapeutic use
  • Bone Marrow Transplantation / adverse effects*
  • Cyclosporine / therapeutic use
  • Cystitis / etiology
  • Cytomegalovirus Infections / drug therapy
  • Cytomegalovirus Infections / etiology
  • Female
  • Fungemia / etiology
  • Ganciclovir / therapeutic use
  • Graft vs Host Disease / prevention & control*
  • Histocompatibility
  • Humans
  • Immunomagnetic Separation*
  • Immunosuppressive Agents / therapeutic use
  • Leukemia / therapy
  • Lung Diseases, Interstitial / etiology
  • Lymphocyte Depletion / methods*
  • Male
  • Methotrexate / therapeutic use
  • Safety
  • Transplantation Conditioning
  • Transplantation, Homologous / adverse effects*
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Antigens, CD
  • Antigens, Differentiation, T-Lymphocyte
  • Antiviral Agents
  • CD6 antigen
  • Immunosuppressive Agents
  • Cyclosporine
  • Ganciclovir
  • Methotrexate