NL-OMON54771已完成2 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •101. Histologically confirmed aggressive B cell NHL, including the following
- •types defined by WHO 2008 (Campo 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
- •- 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 OR
- •- 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
- •- 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:
- 另有 5 项未显示
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
- •216. Primary immunodeficiency
- •217. History of symptomatic deep vein thrombosis or pulmonary embolism requiring
- •systemic anticoagulation 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
- 另有 3 项未显示
研究者
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