Relapsed/Refractory Chronic Lymphocytic Leukemia MedDRA version: 20.0 Level: LLT Classification code 10008977 Term: Chronic lymphocytic leukemia recurrent System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10008978 Term: Chronic lymphocytic leukemia refractory System Organ Class: 100000004864
Conditions
Interventions
Product Code: KTE-X19
Pharmaceutical Form: Dispersion for infusion
INN or Proposed INN: KTE-X19
Current Sponsor code: KTE-X19
Concentration unit: Other
Concentration type: up to
Concentration number:
Sponsors
Kite Pharma, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 101. Documentation of relapsed or refractory CLL; subjects must have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor 102. An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion > 1.5cm in diameter) 103. Adequate hematologic function 104. Adequate renal, hepatic, cardiac and pulmonary function 105. Age 18 or older 106. ECOG performance status of 0 or 1 107. Females of childbearing potential must have a negative serum or urine pregnancy test 108. 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 201. A history of treatment including any of the following: a. Prior CD19 directed therapy b. Treatment with alemtuzumab within 6 months before enrollment c. Prior allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 6 months prior to enrollment d. Live vaccine administration within 4 weeks before enrollment e. Systemic immunosuppression or systemic treatment for any autoimmune disease not related to CLL in the 2 years before enrollment 202. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by IBMTR index 203. History of autoimmune disease resulting in end-organ injury unless attributable to CLL (eg, ITP, AIHA) 204. Diagnosis of Richter's transformation or a history of malignancy. Exceptions include: 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 205. History of severe hypersensitivity reaction attributed to aminoglycosides or any of the agents required for treatment in this study 206. CNS disease 207. History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome 208. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months before enrolment 209. History of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment 210. Primary immunodeficiency 211. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Disease Society of America (IDSA) guidelines or applicable country guidelines. 212. Presence of active fungal, bacterial, viral infection or any infection requiring antimicrobial treatment for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical Monitor 213. Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted 217. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Phase 1: Incidence of DLTs in subjects treated with KTE-X19 Phase 2: Objective response rate (CR/CRi/PR) per independent review as defined by IWCLL 2018 criteria;Timepoint(s) of evaluation of this end point: Phase 1: onset within the first 28 days following KTE-X19 infusion Phase 2: Disease assessment at D28, W8, M3, M6, then every 3 months till M24;Main Objective: Phase 1: Evaluate the safety of KTE-X19 Phase 2: Evaluate the efficacy of KTE-X19 as measured by the objective response rate (ORR) per independent review ;Secondary Objective: Characterize the safety profile and assess additional efficacy endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Complete response (CR/CRi) rate, ORR per investigator review Minimum Residual Disease (MRD) Negative Rate CR/CRi with MRD- (CR/MRD-) rate Duration of response (DOR), Progression-free survival (PFS) Overall survival (OS) Incidence of AEs and clinically significant changes in laboratory values Changes in EQ-5D and FACT-Leu Levels of anti-CD19 CAR T-cells in blood ;Timepoint(s) of evaluation of this end point: Disease Assessment at D28, W8, M3, M6, then every 3 months till M24, then every 6 months till M60, them annually through Year 15 Blood draw at leukapheresis, M3, and every 3 months up to M12 if applicable Safety: onset on or after the KTE-X19 infusion, through the study | — |
Countries
France, Germany, Italy, Spain, United Kingdom, United States
Contacts
Public ContactRegulatory Affairs
Kite Pharma, Inc
Outcome results
None listed