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Clinical Trial 19812

Cancer Type: Malignant Hematology
Interventions:Axicabtagene Ciloleucel (KTE-C19); KTE-C19 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Javier Pinilla-Ibarz

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia

Summary

Objective

Primary objective of Phase 1: Evaluate the safety of KTE-C19 in subjects with r/r CLL. Primary objective of Phase 2: Evaluate the efficacy of KTE-C19 as measured by the objective response rate (ORR) per independent review in subjects with r/r CLL treated with KTE-C19. Secondary objectives are to characterize the safety profile and assess additional efficacy endpoints including complete response (CR/CRi) rate, minimal residual disease negativity (MRD-) rate, CR/CRi with MRD- (CR/MRD-) rate, the duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Additional objectives will include evaluation of exploratory biomarker, pharmacokinetic and pharmacodynamic endpoints

Inclusion Criteria

  • Documentation of relapsed or refractory CLL; patients must have received at least 2 prior lines of treatment, one of which must include a 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
  • Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
  • 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 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, Treatment with alemtuzamab within 6 months before enrollment, allogeneic hematopoietic stem cell transplant (SCT) or donor lymphocyte infusion (DLI) within 6 months prior to enrollment, Live vaccine administration within 4 weeks before enrollment, or Systemic immunosuppression or systemic treatment for any autoimmune disease not related to CLL in the 2 years before enrollment.
  • Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index.
  • 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
  • Other protocol defined Inclusion/Exclusion criteria may apply.