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

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, cancer, UC-961, cirmtuzumab Read More

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/uL
  • 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 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 HIV, HBV, or 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 TSH 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 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).