A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia (ZUMA-8)

Key Inclusion Criteria:

• Documentation of relapsed or refractory CLL; must have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor.
• 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
• At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib) at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists)

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.