Safety and Efficacy of KTE-C19 in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia

Key Inclusion Criteria:

- Documentation of relapsed or refractory CLL AND a minimum of two prior treatment
regimens with progression on treatment with ibrutinib

- An indication for treatment per IWCLL 2018 criteria and radiographically measurable
disease (at least 1 lesion > 1.5 cm in diameter)

- Adequate hematologic function as indicated by:

- Platelet count ≥ 50 × 10^9/L

- Neutrophil count ≥ 0.5 × 10^9/L

- Hemoglobin ≥ 8 g/dL unless lower values are attributable to CLL

- Adequate renal, hepatic, cardiac and pulmonary function defined as:

- Creatinine clearance (as estimated by Cockcroft-Gault) ≥ 60 mL/min

- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x
upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL unless subject has Gilbert's syndrome

- Left ventricular ejection fraction (LVEF) ≥ 50%, no evidence of pericardial
effusion, no New York Heart Association (NYHA) class III or IV functional
classification, no clinically significant arrhythmias

- No clinically significant pleural effusion

- Baseline oxygen saturation > 92% on room air

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

- A history of treatment including any of the following:

- Prior CD19 directed therapy

- Prior allogeneic hematopoietic stem cell transplant (SCT) or donor lymphocyte
infusion (DLI) within 6 months prior to enrollment

- History of autoimmune disease resulting in end-organ injury unless attributable to CLL
(eg, idiopathic thrombocytopenic purpura (ITP), autoimmune hemolytic anemia (AIHA))

- Diagnosis of Richter's transformation or a history of malignancy other than
non-melanoma skin cancer or carcinoma in situ (eg, skin, cervix, bladder, breast),
superficial bladder cancer, asymptomatic localized low grade prostate cancer for which
watch-and-wait approach is standard of care, or any other cancer that has been in
remission for > 3 years prior to enrollment

- History of severe hypersensitivity reaction attributed to aminoglycosides

Note: Other protocol defined Inclusion/Exclusion criteria may apply.