EUCTR2015-005009-35-NL进行中（未招募）1 期
A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3) - ZUMA-3
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Relapsed or refractory B-precursor ALL defined as one of the
- •- Primary refractory disease
- •- First relapse if first remission = 12 months
- •- Relapsed or refractory disease after two or more lines of systemic therapy
- •- Relapsed or refractory disease after allogeneic transplant provided subject is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
- •102. Morphological disease in the bone marrow (> 5% blasts)
- •103. Subjects with Ph+ disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
- •104. Age 18 or older
- •105. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
- •106. ANC = 500/uL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
- •107. Platelet count = 50,000/uL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia
- •108. Absolute lymphocyte count = 100/µL
- •109. Adequate renal, hepatic, pulmonary and cardiac function defined as:
- •- Creatinine clearance (as estimated by Cockcroft Gault) = 60 cc/min
- •- Serum ALT/AST = 2.5 x ULN (upper limit normal)
- •- Total bilirubin = 1.5 mg/dl, except in subjects with Gilbert's syndrome.
- •- Left ventricular ejection fraction (LVEF) = 50%, no evidence of pericardial effusion as determined by an ECHO, no NYHA class III or class IV functional classification, and no clinically significant arrhythmias
- •- No clinically significant pleural effusion
- •- Baseline oxygen saturation > 92% on room air
- •110. Females of childbearing potential must have a negative serum or urine pregnancy test
- •111. In subjects previously treated with blinatumomab, CD19 tumor expression on blasts obtained from bone marrow or peripheral blood must be documented after completion of the most recent prior line of therapy. If CD19 expression is quantified, then blasts must be = 90% CD19 positive.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •201. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
- •202. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- •203. History of severe hypersensitivity reaction to aminoglycosides or any of the agents used in this study
- •204. CNS abnormalities
- •a.Presence of CNS-3 disease, defined as detectable cerebrospinal blast cells in a sample of CSF with = 5 WBCs per mm3 with or without neurological changes, and presence of CNS-2 disease defined as detectable cerebrospinal blast cells in a sample of CSF with <5 WBCs per mm3 with neurological changes. Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study.
- •b.History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema
- •205. History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome.
- •206. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- •207. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- •208. Primary immunodeficiency
- •209. Known infection with HIV, 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 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
- •211. Prior medication:
- •-Salvage systemic chemotherapy (including chemotherapy, TKIs for Ph+ ALL and blinatumomab, within 1 week or 5 half-lives (whichever is shorter) prior to enrollment
- •-Prior CD19 directed therapy other than blinatumomab
- •-History of CTCAE grade 4 neurologic event or grade 4 CRS (Lee 2014) with prior CD19-directed therapy
- •-Treatment with alemtuzumab within 6 months prior to enrollment, clofarabine or cladribine within 3 months prior to enrollment, or PEG-asparaginase within 3 weeks prior to enrollment
- •-Donor lymphocyte infusion (DLI) within 28 days prior to enrollment
- •-Any drug used for GVHD within 4 weeks prior to enrollment (e.g. calcineurin inhibitors, methotrexate, mycophenolyate, rapamycin, thalidomide, or immunosuppressive antibody used within 4 weeks prior to enrollment (eg, anti-CD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor)
- •-At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists etc)
- •-Corticosteroid therapy at a pharmacologic dose (> 5 mg/day of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs mu
研究者
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