EUCTR2015-005008-27-ES进行中（未招募）1 期
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) (ZUMA-2) - ZUMA-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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. Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or presence of t(11;14)
- •102. Up to 5 prior regimens for MCL.
- •Cohort 1 and Cohort 2: Prior therapy must have included:
- •- Anthracycline or bendamustine-containing chemotherapy and
- •- Anti-CD20 monoclonal antibody therapy and
- •- Ibrutinib or acalabrutinib
- •Cohort 3: Prior therapy must have included anthracycline- or bendamustine-containing
- •chemotherapy and anti-CD20 monoclonal antibody therapy. Subjects in Cohort 3 must
- •not have received prior therapy with a BTKi.
- •103. Relapsed or refractory disease, as defined by the following:
- •- Disease progression after last regimen, or
- •- Failure to achieve a PR or CR to the last regimen
- •104. At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. If the only measurable disease is lymph node disease, at least one lymph node should be = 2 cm
- •105. MRI of the brain showing no evidence of CNS lymphoma
- •106. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib; if applicable) 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 (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists etc).
- •107. Toxicities due to prior therapy must be stable and recovered to = Grade 1 (except for clinically non-significant toxicities such as alopecia)
- •108. Age 18 years or older
- •109. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •110. ANC = 1000/uL
- •111. Platelet count = 75,000/uL
- •112. Absolute lymphocyte count = 100/ uL
- •113. Adequate renal, hepatic, pulmonary and cardiac function defined as:
- •- Creatinine clearance (as estimated by Cockcroft Gault) = 60 cc/min
- •- Serum ALT/AST = 2.5 ULN
- •- Total bilirubin = 1.5 mg/dl, except in subjects with Gilbert’s syndrome
- •- Cardiac ejection fraction = 50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings
- •- No clinical significant pleural effusion
- •- Baseline oxygen saturation > 92% on room air
- •114. 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.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •201. History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years.
- •202. Autologous stem cell transplant within 6 weeks of planned KTE-X19 or axicabtagene ciloleucel infusion.
- •203. History of allogeneic stem cell transplantation (alloSCT)
- •204. Prior CD19 targeted therapy with the exception of subjects who received KTE-X19 or axicabtagene ciloleucel in this study and are eligible for re-treatment.
- •205. Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
- •206. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- •207. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite Medical Monitor.
- •208. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection. Subjects with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing.
- •209. Presence of any indwelling line or drain (e.g. percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
- •210. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
- •211. History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome (PRES), or any autoimmune disease with CNS involvement
- •212. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmias, or other clinically significant cardiac disease within 12 months of enrollment
- •213. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- •214. History of deep vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within 6 months of enrollment
- •215. Possible requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, tumor mass effect, tumor lysis syndrome)
- •216. Primary immunodeficiency
- •217. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
- •218. History of severe immediate hypersensitivity reaction to any of the agents used in this study
- •219. Live vaccine = 6 weeks prior to planned start of conditioning regimen
- •220. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant
- •221. Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of KTE-X19 or axicabtagene ciloleucel infusion
- •222. In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
- •223. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression and/or s
研究者
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