This study will test different doses of anti-CD74 antibody in patients with NHL and/or CLL.
Milatuzumab (hLL1, IMMU-115), a humanized anti-CD74 monoclonal antibody. Dose escalation will utilize 4 planned dose regimens with 4.0 or 8.0 mg/kg doses administered intravenously either twice weekly (days 1 and 4) or thrice weekly (days 1, 3 and 5) for 4 consecutive weeks. The four planned dose regimens will be labeled as dose level 1 to 4 corresponding to increasing levels of the total dose of milatuzumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
two or three times a week dosing of hLL1 for a total of 4 weeks
Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Georgetown University Hospital Lombardi Cancer Center
Washington D.C., District of Columbia, United States
M. D. Anderson Cancer Center
Orlando, Florida, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Safety of the anti-CD74 antibody will be evaluated based upon physical examinations, hematology and chemistry laboratory evaluations and toxicity events
Time frame: over first 12 weeks
Efficacy (to see if the study drug works) in patients with NHL and CLL
Time frame: over the first 12 weeks, then over up to 2 years
Pharmacokinetics (how the drug is processed by the body)
Time frame: over the first 12 weeks
Pharmacodynamics (how the study drug is absorbed by the body)'
Time frame: over the first 12 weeks, then over 2 years
Immunogenicity
Time frame: over at least first 12 weeks
optimal dose
Time frame: first 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MD Anderson Cancer Center
Houston, Texas, United States