NL-OMON54549招募中2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
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. 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, bendamustine-, or high dose cytarabine-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. For subjects in cohort 1
- •and cohort 2 only: 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; as applicable
- •for subjects in cohort 1 and cohort 2) 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. For
- •subjects in cohort 3 with bone marrow involvment, platelet count >50,000/uL
- •is acceptable 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. For subjects in cohort 3,
- •a multigated acquisition (MUGA) scan may be used in place of ECHO. - No
- •clinicallly significant pleural effusion for subjects in cohort 1 and cohort 2
- •and no clinically significant pleural effusion, pericardial effusion, or
- •ascites for subjects in cohort 3. - 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.
排除标准
- •201. History of malignancy other than non-melanomatous 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, with the exception of subjects in cohort 3 with no donor cells
- •detected on chimerism >100 days after 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
- •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. Females 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. 222. In the
- •investigators judgment, the subject is unlikely to complete all
- •protocol-required study visits or procedures, includ
研究者
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