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Blood, Vol. 92 No. 11 (December 1), 1998:
pp. 4066-4071
A Phase II Study of BTI-322, a Monoclonal Anti-CD2 Antibody, for
Treatment of Steroid-Resistant Acute Graft-Versus-Host Disease
Donna Przepiorka,
Gordon L. Phillips,
Voravit Ratanatharathorn,
Michele Cottler-Fox,
Laurie H. Sehn,
Joseph H. Antin,
Donna LeBherz,
Michel Awwad,
James Hope, and
J. Bruce McClain
From The University of Texas M.D. Anderson Cancer Center, Houston;
the University of Kentucky Chandler Medical Center, Lexington; the
University of Michigan Medical Center, Ann Arbor; the University of
Maryland Greenebaum Cancer Center, Baltimore; Brigham and Women's
Hospital, Dana-Farber Cancer Institute, Boston, MA; BioTransplant, Inc,
Charlestown, MA; and MedImmune, Inc, Gaithersburg, MD.
BTI-322, a rat monoclonal IgG2b directed against the CD2 antigen on
T cells and natural killer (NK) cells, blocks primary and memory
alloantigen proliferative responses in vitro. We have evaluated the
pharmacokinetics and safety of BTI-322 during treatment of 20 transplant recipients with steroid-refractory acute graft-versus-host disease (GVHD). Treatment consisted of BTI-322 by intravenous (IV)
bolus or 30-minute infusion at approximately 0.1 mg/kg/d for 10 days in
addition to continuing high-dose steroids and tacrolimus or
cyclosporine. Pharmacokinetic sampling was performed in 10 patients;
the t1/2 ± SE was 9.1 ± 1.3 hours, the Cmax
was 2,549 ± 291 ng/mL, the Vd was 3.97 ± 0.95 L, and
the Vd/kg was 0.05 ± 0.01 L/kg. Ten patients experienced transient
dyspnea sometimes accompanied by nausea, vomiting, diarrhea, and
tachycardia shortly after the initial bolus dose of drug, but serious
drug-related adverse events were not seen during the remainder of the
infusions. At the end of treatment (day 11), there were six patients
with complete responses and five with a reduction in grade of GVHD for
a total response rate of 55% (95% confidence interval
[CI], 32% to 77%). Antibodies targeting CD2 may be
active in the treatment of acute GVHD, and evaluation of a humanized
form of BTI-322 is warranted.
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