This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Ohio State University Medical Center
Columbus, Ohio, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Overall Response Rate (ORR)
ORR= CR (Complete Remission) + PR (Partial Remission) Antitumor activity of MOR00208
Time frame: Throughout during study until progression, after each treatment cycle
Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT
Two patients had a response to treatment. For one of the two patients a progression was recorded, the other patient was censored due to an AE. Conse quently, the planned Kaplan-Meier analyses of response duration and time to hematological relapse could not be calculated.
Time frame: Throughout during study until progression, after each treatment cycle
Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
Number of patients with at least one treatment-emergent AE
Time frame: weekly, up to 7 months
Pharmacokinetics of MOR00208
Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)
Time frame: weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)
Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity
Time frame: monthly, up to 7 months
Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
Number of patients with treatment-emergent AEs
Time frame: weekly, up to 7 months
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