IMMU-114 will be studied at different dose schedules and dose levels in order to assess the highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the skin). IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest. This is considered one cycle. Treatment cycles will be repeated until toxicity or worsening of disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
hL243 is a humanized antibody that targets HLA-DR, which is found on various b-cell hematologic malignancies and in autoimmune diseases.
Helen F Graham Cancer Center
Newark, Delaware, United States
Nancy N. and J.C. Lewis Cancer and Research Pavilion
Savannah, Georgia, United States
Indiana University Health Goshen Hospital
Goshen, Indiana, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Huntsman Cancer Institute, Univ. Utah
Salt Lake City, Utah, United States
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Safety will be assessed by measuring the change from baseline during treatment and up to 30 days after treatment
Clinical Response: o Measured by International Working Group Criteria for NHL patients. o Measured by IWCLL 2008 Guidelines for CLL patients.
Responders will be defined as those with complete response (CR) or partial response (PR). Overall response rate (ORR) will be calculated as the number of evaluable responders divided by the total number of evaluable patients.
Time frame: Efficacy will be assessed every 12 weeks during treatment and 4 weeks after the end of treatment
Progression Free Survival
Time frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
Overall Survival
Time frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
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