SHS_492451 PAGJ CKIT 18141

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects 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.
Phase I/II
John Pagel, M.D.
Kite Pharma, Inc
Paul Wisniewski
  • Swedish Medical Center