UC-961 (Cirmtuzumab) in Relapsed or Refractory Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT02222688|
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: cirmtuzumab||Phase 1|
This is a first in human, open-label single institution, Phase I dose escalation study of in patients with relapsed or refractory CLL. Treatment cycle (14 days) will consist of cirmtuzumab administered intravenously on a bi-weekly (every two weeks) schedule for a total of 4 doses. Eight dose cohorts (of 3 to 6 patients in size) plus an expansion cohort of 6 patients are planned. In the first 4 dose cohorts, there is intra-patient dose escalation to monitor for acute toxicities, such as tumor lysis syndrome.
A cycle may be repeated every 14 days if the patient has at least stable disease by clinical examination (or interim response assessment) and has again met hematologic, renal, and hepatic laboratory parameters as defined in the eligibility section, and is without ongoing Grade 3 non-hematologic or Grade 4 hematologic toxicities attributable to cirmtuzumab. The total duration of study drug administration is 4 cycles. Each cycle consists of clinical and laboratory evaluation on Day 1 and safety assessments on Days 3 and 8.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Trial to Determine the Safety and Tolerability of UC-961 (Cirmtuzumab), an Anti-ROR1 Monoclonal Antibody, for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Are Ineligible for Chemotherapy|
|Actual Study Start Date :||August 8, 2014|
|Actual Primary Completion Date :||October 10, 2017|
|Actual Study Completion Date :||May 1, 2018|
The starting dose is 15 µg/kg. There is intra-patient dose escalation in the first 4 cohorts, followed by the standard 3+3 design for the subsequent cohorts until a maximum tolerated dose (MTD) or biologically active dose is reached. If there is a grade ≥ 2 adverse event in the cohorts with intra-patient dose escalation, then the dose escalation scheme will switch to a standard 3+3 dose-escalation design without intra-patient dose escalation.
Other Name: UC-961
- Determine the maximum tolerated dose (MTD) or biologically active dose of Cirmtuzumab [ Time Frame: 1 year ]The MTD is defined as the highest dose studied at which no more than one in six patients experience a dose-limiting toxicity (DLT) during the DLT observation period. The biologically active dose will be determined at a dose below or equal to the MTD upon review of the the study data; the final determination will also consider any cumulative or delayed toxicity.
- Determine the rate of dose limiting toxicities (DLTs) [ Time Frame: The DLT observation period is 56 days from the start of the first infusion for the intra-patient dosing cohorts and 28 days after the start of the first infusion for subsequent dosing cohorts ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222688
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Catriona Jamieson, M.D., Ph.D.||University of California Medical Center|
|Principal Investigator:||Michael Choi, M.D.||University of Calilfornia Medical Center|