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A phase 1 study of adoptive transfer of autologous CD8+ T lymphocytes in
patients with acquired immunodeficiency syndrome (AIDS)-related complex or
AIDS
M Ho, J Armstrong, D McMahon, G Pazin, XL Huang, C Rinaldo, T Whiteside, C Tripoli, G Levine and D Moody
Department of Infectious Diseases and Microbiology, Graduate School of
Public Health, PA 15261.
Based on preclinical studies showing that CD8+ T lymphocytes of human
immunodeficiency syndrome (HIV)-infected subjects have anti-HIV activities,
a phase 1 study was undertaken to determine the safety and feasibility of
infusing in vitro purified, activated, and expanded CD8+ cells as a
therapeutic measure in seven patients with acquired immunodeficiency
syndrome (AIDS)-related complex (ARC) or AIDS. Autologous CD8+ cells were
first selectively isolated in monoclonal antibody-coated flasks from
peripheral blood mononuclear cells recovered by leukapheresis. They were
then cultured and expanded with phytohemagglutinin and recombinant
interleukin-2 (rIL-2) before infusion. Five cycles of isolations and
infusions of increasing numbers of CD8+ T cells were achieved in five of
seven subjects. Five cycles could not be completed in two subjects with
AIDS whose CD4+ cell counts were < or = 48/microliters. Infusions of
CD8+ cells alone were well tolerated. Four patients received rIL-2 by
continuous infusion for 5 days with their final cycle of CD8+ cells. All
developed reversible adverse effects attributable to rIL-2. After infusion,
111In-labeled CD8+ cells quickly accumulated in the lungs, with less than
10% of the labeled cells remaining in the circulation. After 24 hours,
labeled CD8+ cells were reduced in the lungs, but increased and persisted
in liver, spleen, and bone marrow. Four of five patients who were treated
with multiple infusions of CD8+ cells have improved or remained clinically
stable, and the fifth developed Pneumocystis carinii pneumonia but
recovered. This study demonstrated that infusion of autologous, in vitro
expanded and activated CD8+ cells was feasible and clinically well
tolerated in five of seven subjects with advanced HIV infections.
Volume 81,
Issue 8,
pp. 2093-2101,
04/15/1993
Copyright © 1993 by The American Society of Hematology
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