EUCTR2018-001923-38-DE进行中（未招募）1 期
Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia - ZUMA-8
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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
研究者
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