EUCTR2015-005007-86-FR进行中（未招募）1 期
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE C19 in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL) (ZUMA-1) - ZUMA-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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. Histologically confirmed aggressive B cell NHL, including the following types defined by WHO 2008:
- •- DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV)+ DLBCL of the elderly; OR
- •- primary mediastinal (thymic) large B cell lymphoma
- •- transformation of follicular lymphoma to DLBCL will also be included
- •102. Chemotherapy-refractory disease, defined as one or more of the following:
- •- No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded
- •- PD as best response to first-line therapy
- •- SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) with SD duration no longer than 6 months from last dose of therapy
- •- No response to second or greater lines of therapy
- •- PD as best response to most recent therapy regimen
- •- SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy
- •- Refractory post-ASCT
- •- Disease progression or relapsed =12 months of ASCT (must have biopsy proven recurrence in relapsed subjects)
- •- if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
- •103. Subjects must have received adequate prior therapy including at a minimum:
- •- anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
- •- an anthracycline containing chemotherapy regimen;
- •- for subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL
- •104 .At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
- •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 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 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 mL/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 clinically 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
排除标准
- •201. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
- •202. History of Richter’s transformation of CLL
- •203. Autologous stem cell transplant within 6 weeks of planned KTE-C19 infusion
- •204. History of allogeneic stem cell transplantation
- •205. Prior CD19 targeted therapy with the exception of subjects who received KTE-C19 in this study and are eligible for re-treatment
- •206. Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
- •207. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- •208. 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
- •209. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing
- •210. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
- •211. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
- •212. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- •213. Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- •214. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- •215. Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
- •216. Primary immunodeficiency
- •217. History of deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- •218. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
- •219. History of severe immediate hypersensitivity reaction to any of the agents used in this study
- •220. Live vaccine = 6 weeks prior to planned start of conditioning regimen
- •221. 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. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
- •222. 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-C19
- •223. 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
- •224. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying
研究者
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