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Safety and Efficacy of KTE-X19 in Adults With Relapsed / Refractory Chronic Lymphocytic Leukemia

Trial Status: Closed to Accrual

The primary objective of this study is to evaluate the safety (Phase 1) and efficacy (Phase 2) of KTE-X19 in adults with relapsed / refractory chronic lymphocytic leukemia (r / r CLL).

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)

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

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Steven Singer
Phone: 310-825-4477
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Dana Wheeler
Phone: 913-945-7550

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Minnesota

Rochester
Mayo Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Kite, A Gilead Company

  • Primary ID KTE-C19-108
  • Secondary IDs NCI-2018-02958, 2018-001923-38
  • Clinicaltrials.gov ID NCT03624036