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The study will also compare the efficacy and safety of two dosage regimens of KTE-C19. Inclusion Criteria {#Sec2} ------------------ Subjects are eligible for inclusion if they are ≥ 18 years of age with: relapsed or refractory chronic lymphocytic leukemia (CLL) B-cell count ≥ 5 × 10^9^/L (normal range is up to 5 × 10^9^/L) at screening and/or at the first CLL assessment 2 weeks post-treatment (Phase 1) or relapsed or refractory CLL B-cell count ≥ 5 × 10^9^/L and ≥ 50% lymphocytes at screening and/or at the first CLL assessment 2 weeks post-treatment (Phase 2)Cytogenetic abnormalities in CLL cells in a Phase 1a CLL patient (with no abnormalities in normal hematopoietic cells)History of having received prior treatment with at least one of the following: (a) rituximab, (b) fludarabine, (c) cladribine, (d) cyclophosphamide, (e) azacitidine, and/or (f) bendamustineCytogenetic abnormalities in CLL cells in a Phase 2 CLL patient (with no abnormalities in normal hematopoietic cells)History of having received prior treatment with alemtuzumab or OKT3. Exclusion Criteria {#Sec3} Subjects are excluded if they have any of the following: had an autologous or allogeneic stem cell transplantation or humanized monoclonal antibody treatment within 6 months prior to study entry; a history of breast cancer; central nervous system, solid organ, or hematopoietic stem cell transplantation within 1 year prior to study entry; malignant solid tumors, excluding treatment-naïve basal cell carcinoma, or malignant melanoma (patients who have a history of basal cell carcinoma, melanoma, or squamous cell carcinoma of the skin are allowed to participate); pregnancy, breastfeeding, or intent to become pregnant during the study; positive test for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; or any autoimmune disease or

 

 


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