Phase I Study of Subcutaneous Ocaratuzumab 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.