Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mentrik Biotech, LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies
