A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of chronic, advanced, progressive multiple sclerosis (MS) --Prior/Concurrent Therapy-- Biologic therapy: No sensitivity to murine proteins No prior treatment at any time with anti-CD4 antibodies, other murine antibodies, or other anti-T cell antibodies (e.g., xenologous or human) At least 4 weeks since use of other biological agents Chemotherapy: No concomitant chemotherapy At least 3 months since prior chemotherapy Endocrine therapy: No concomitant steroidal therapy At least 3 months since prior steroidal therapy Radiotherapy: No total lymphoid irradiation prior to study No concomitant radiotherapy At least 3 months since prior radiotherapy Other: No use of investigational drugs within 30 days prior to study --Patient Characteristics-- Age: 21 to 75 Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4000/mm3 Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 CD4+ lymphocyte count at least 300 cells/mm3 Other: Not pregnant or lactating Effective contraception required of fertile patients for 3 months prior to and during study No substance abuse (e.g., drug or alcohol) Not HIV positive No AIDS-Related Complex (ARC) No serum antibodies to HIV Negative serum antibody test for HIV within 1 month prior to study No underlying medical or psychiatric condition