Chronic Lymphocytic Leukemia Clinical Trial
Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory leukemia-cll/" >chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor.
After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968.
Key Inclusion Criteria:
Documentation of relapsed or refractory CLL and SLL; must have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor.
Cohort 1 and 2: Participants with r/r CLL who have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor.
Cohort 3: Participants with r/r CLL and SLL must present with ≤ 1% circulating tumor cells in peripheral blood or absolute lymphocyte count (ALC) < 5000 cells/μL. Participants must have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor.
Cohort 4: Participants with r/r CLL who have received at least 2 prior lines of treatment and must have received ibrutinib as a single agent or in comibation with anti-cluster of differentiate 20 (CD20) antibodies, B-cell lymphoma 2 (BCL-2) inhibitors, and phosphoinositide 3-kinase inhibitor (PI3k) inhibitors for at least 6 months as the last line of therapy prior to screening. Ibrutinib administration will continue up to 30 hours prior to leukapheresis. In case of treatment interruption with ibrutinib, the principal investigator should reach out to the medical monitor to discuss.
An indication for treatment per International Workshop on Chronic Lymphocytic Leukemia (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 participant 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 participant 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 participant 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 cluster of differentiate 19 (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.
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There are 22 Locations for this study
Phoenix Arizona, 85054, United States
Los Angeles California, 90095, United States
Stanford California, 94035, United States
Denver Colorado, 80218, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Seattle Washington, 98104, United States
Milano , 20132, Italy
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