Status:
UNKNOWN
Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies
Lead Sponsor:
Mentrik Biotech, LLC
Conditions:
Previously Treated CD20+ B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased bindi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01858181
Start Date
January 1 2015
Last Update
March 3 2014
Active Locations (1)
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1
Universtity of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390