A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies
Inclusion Criteria:
- Age >18 years;
- Histologically confirmed diagnosis of a CD20+ B-cell malignancy;
- Received at least one prior treatment regimen;historically documented
CD20-positivity is acceptable;
- Appropriate for single agent study drug therapy as prescribed by this protocol;
- ECOG performance status 0 to 2;
- Adequate hematopoietic, renal, and hepatic functions defined as:
- Absolute neutrophil count greater than 1000 /mm³
- Platelet count greater than 75,000/mm³
- Hemoglobin greater than 8.5 g/dL
- Serum creatinine ≤ 1.5x upper limit of normal
- AST, ALT, and total bilirubin ≤ 3x upper limit of normal;
- Ability to understand and the willingness to sign a written informed consent
document;
- Life expectancy of 6 months or greater.
Exclusion Criteria:
- Anti-CD20 therapy within 4 weeks of enrollment;
- Systemic chemotherapy or immunotherapy within 14 days of enrollment;
- Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or
greater;
- Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly
while participating on this study;
- Active infection, chronic or severe infection requiring ongoing antimicrobial
therapy.
- Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as
HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be
excluded;
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition;
- Significant cardiac disease (New York Heart Association classes III or IV) or
unstable angina despite medication;
- Women who are pregnant or breast-feeding;
- Women of child bearing potential who are unwilling to use effective contraception for
the duration of the study drug administration and 6 months after final dose of drug
is administered;
- Psychiatric illness/social situations that would limit compliance with study
requirements;
- Participation in other investigational studies while enrolled on this trial.