CTIS2022-502907-31-00进行中（未招募）1 期
A Phase II study evaluating efficacy of KTE-X19 CAR-T cell therapy in Relapsed or Refractory Mantle-Cell Lymphoma achieving a partial response during Ibrutinib salvage therapy - PRIMACART
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 65+（—）
- 性别
- All
入选标准
- •Signed Informed Consent Forms (ICF), Negative urine and serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential who are considered to be post-menopausal(= 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test, Female patients of reproductive potential should avoid becoming pregnant by using a highly effective method of contraception or abstaining from sexual activity from the time of consent through 12 months following lymphodepletion chemotherapy administration or 12 months after KTE-X19 infusion, Male patients of reproductive potential, even if surgically sterilized (ie, status post-vasectomy), should use an effective method of contraception and are recommended to use a barrier method or abstain from sexual activity from the time of consent through 12 months following lymphodepletion chemotherapy administration or 12 months after KTE-X19 infusion., Patients must be accessible for treatment and follow up as well as they must be willing and capable to comply with the requirements of the study, Confirmed availability of archival, Life expectancy of at least 12 weeks, Age = 18 years and = 75 years, ECOG performance status of 0 or 1, Histologically confirmed diagnosis of mantle-cell lymphoma according to the 2016 WHO classification, Relapsed or refractory disease after at least one line of systemic therapy prior to Ibrutinib treatment, including anthracyclines or bendamustine in association with Rituximab, Currently receiving Ibrutinib at time of enrollment, without drug tolerance issues, PET/CT/Magnetic Resonance Imaging (MRI) confirmed and measurable PR disease status, as defined by the Lugano Response Criteria 11 (Cheson, 2014), after a minimum of 6 months of Ibrutinib single agent treatment as current line of therapy at time of enrollment, Hematologic laboratory values: Lymphocyte counts = 0.1 x 10^9/L at time of enrollment, Absolute neutrophil count (ANC) = 1.0 x 10^9/L, without growth factor support for 7 days (14 days if pegfilgrastim), Untransfused Hemoglobin (Hb) = 8 g/dL, Platelets (PLT) = 75 x 10^9/L or = 30 x 10^9/L in case of documented bone marrow involvement (> 50% or tumor cells), without transfusion for 7 days, Adequate organ function; Adequate liver function: aspartate aminotransferase / serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase / serum glutamic pyruvic transaminase (ALT/SGPT) = 2.5 x ULN; serum total bilirubin = 1.5 ULN except in cases of Gilbert’s syndrome, then = 3.0 ULN; Adequate renal function: estimated serum creatinine clearance of = 60 mL/min calculated by Cockroft-Gault formula; Adequate cardiac function: ejection fraction = 50%; Adequate lung function: SO2 > 92% at rest and absence of pleural effusions
排除标准
- •Patients with a known or suspected history of HLH/MAS, Received any other investigational drugs within 30 days before enrollment., Active central nervous system (CNS) involvement by lymphoma, or current or past history of other CNS disease, such as stroke, epilepsy, dementia, CNS vasculitis, neurodegenerative disease, cerebral edema or progressive multifocal leukoencephalopathy (PML); Note: Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed, History of deep venous thrombosis or pulmonary embolism in 6 months prior to participation in the study, Significant or extensive history of cardiovascular disease such as New York Heart Association (NYHA) Class III or IV or Objective Class C or D cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina, Patients with another invasive malignancy, with the exception of non-melanomatous skin cancer or carcinoma in situ, and other tumors deemed by the investigator to be of low likelihood for recurrence, unless disease-free for at least 3 years, Any medical condition likely to interfere with assessment of safety or efficacy study treatment, Patients with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to apheresis and lymphodepleting chemotherapy or by clinical judgment in the absence of a positive blood culture, Patients with known active infection, or reactivation of a latent infection, whether bacterial, viral [including, but not limited to, epstein barr virus (EBV), cytomegalovirus (CMV), hepatitis B (HBV), hepatitis C (HCV), and HIV], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing. If there is a positive history of HBV or HCV, the viral load must be undetectable per quantitative PCR and/or nucleic acid testing, Pregnant, breast-feeding, or intending to become pregnant during the study, Prior exposure to CAR-T cell therapy, Prior solid organ transplantation, History of allogenic HSCT except if no donor cells are detected on chimerism, the subject is off all immunesuppression, and there is no evidence of active graft-versus-host-disease (GVHD) of any grade, acute or chronic, History of autoimmune disease causing clinically significant organ dysfunction or requiring systemic immune suppression or disease-modifying agents in the two years prior to the participation in this study, Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to leukapheresis. Inhaled and topical steroids are permitted.
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