Extension Study of UC-961 (Cirmtuzumab) for Patients With Chronic Lymphocytic Leukemia Treated Previously With UC-961

Inclusion Criteria:

* Clinical and phenotypic verification of B cell CLL and measurable disease. Immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g., co-expressing CD19 and CD5).
* Recovered from toxic effects attributed to UC-961 to grade 1 levels, or baseline.
* Must have measurable disease, including one of the following:

  * absolute lymphocyte count greater than 5000/microliter
  * lymphadenopathy greater than 1.5 cm in longest dimension
  * splenomegaly
  * bone marrow biopsy with residual CLL cells, or resultant bone marrow dysfunction
* Women of childbearing potential must agree not to become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 10 weeks after the final dose of UC-961.
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Adequate hematologic function
* Adequate renal function
* Adequate hepatic function
* Adequate coagulation tests

Exclusion Criteria:

* Pregnant or breast-feeding women
* May have had intervening therapy since completion of initial UC-961 dosing, but excluding the following:

  * Within 7 days of UC-961 restart, or 5 half-lives (if known), whichever is shorter: small molecule tyrosine kinase inhibitor (eg: ibrutinib, idelalisib, AVL-292, IPI-145);
  * Within 28 days of UC-961 restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-961);
  * Within 56 days of UC-961 restart: previous UC-961 dosing;
  * Within 56 days of UC-961 restart: monoclonal antibody therapy directed against CLL (e.g., rituximab, ofatumumab, obinutuzumab, alemtuzumab).
* Current infection requiring parenteral antibiotics.
* Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
* Concurrent malignancy or prior malignancy within the previous 3 years (other than completely resected carcinoma in situ, prostate cancer, or localized non-melanoma skin cancer).
* Known central nervous system (CNS) involvement by malignancy.
* Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
* Uncompensated hypothyroidism (defined as thyroid stimulating hormone greater than 2x upper limit of normal not treated with replacement hormone).
* Presence of more than 55% pro-lymphocytes in peripheral blood. Patients with Richter's transformation are not excluded.
* Insufficient recovery from surgical-related trauma or wound healing.
* Impaired cardiac function including any of the following:

  * Myocardial infarction within 6 months of starting study drug;
  * A past medical history of clinically significant electrocardiogram (ECG) abnormalities;
  * Other clinically significant heart disease (e.g. uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).