title: Induction immunotherapy in heart transplantation with T10B9.1A-31: a phase I study.
abstract: Cytolytic induction therapy of heart transplantation with OKT3 (immunoglobulin G2a isotype, anti CD3 idiotype) or T10B9.1A-31 (immunoglobulin MK isotype, anti-T-cell receptor alpha beta idiotype) was done in an open-label trial to determine the safety and efficacy of the latter monoclonal antibody. A total of nine patients undergoing orthotopic heart transplantation received a 10-day course of either T10B9.1A-31 (T10B9) (n = 4) 18 mg on bypass and 6 mg intravenously every 12 hours or OKT3 (n = 5) 10 mg on cardiopulmonary bypass and 5 mg intravenously daily. Endomyocardial biopsy surveillance revealed no rejection during induction therapy with T10B9, and one OKT3 induction failure was successfully treated with T10B9, all without significant side effects. T10B9 effectively prevented the onset of early acute rejection in heart transplantation with minimal side effects. T10B9 reversed rejection in one patient whose OKT3 induction failed. Results are encouraging and warrant further investigation.
authors.affiliation: Division of Nephrology, Bone and Mineral Metabolism, University of Kentucky Medical Center, Lexington 40536-0084, USA.
authors.forename: T H
authors.initials: TH
authors.lastname: Waid
authors.forename: J S
authors.initials: JS
authors.lastname: Thompson
authors.forename: J W
authors.initials: JW
authors.lastname: McKeown
authors.forename: S A
authors.initials: SA
authors.lastname: Brown
authors.forename: M E
authors.initials: ME
authors.lastname: Sekela
mesh_terms: D000328:Adult; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001706:Biopsy; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004699:Endocardium / Q000276:immunology / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000276:immunology / Q000473:pathology / Q000517:prevention & control; D016027:Heart Transplantation / Q000276:immunology* / Q000473:pathology; D006801:Humans; D007132:Immunoglobulin Isotypes / Q000276:immunology*; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016853:Muromonab-CD3 / Q000008:administration & dosage / Q000009:adverse effects; D009206:Myocardium / Q000276:immunology / Q000473:pathology; D016693:Receptors, Antigen, T-Cell, alpha-beta / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D007132:Immunoglobulin Isotypes; D007166:Immunosuppressive Agents; D016853:Muromonab-CD3; D016693:Receptors, Antigen, T-Cell, alpha-beta; D016572:Cyclosporine