EUCTR2015-005007-86-NL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
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
- 246
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
入选标准
- •101. Histologically confirmed aggressive B cell NHL, including the following types defined by WHO 2008 (Campo et al, 2011):
- •- 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 et al, 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
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 with therapeutic intent within 6 weeks of planned axicabtagene ciloleucel infusion
- •204. History of allogeneic stem cell transplantation
- •205. Prior CD19 targeted therapy with the exception of subjects who received axicabtagene ciloleucel 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 or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
- •209. History of 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 Diseases Society of America (IDSA) guidelines or applicable country guidelines.
- •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 or primary 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. Expected or possible requirement for urgent therapy within 6 weeks due to ongoing or impending oncologic emergency (eg, tumor mass effect, tumor lysis syndrome)
- •216. Primary immunodeficiency
- •217. History of symptomatic 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 dange
研究者
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