NL-OMON55408已完成2 期
A phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) - CCTL019C2201 (CART-DLBCL)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 5
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 99（—）
入选标准
- •1) Written informed consent must be obtained prior to any screening
- •2) Histologically confirmed DLBCL at last relapse (by central pathology review
- •before enrolment)
- •3) Relapsed or refractory disease after *2 lines of chemotherapy, including
- •rituximab and anthracycline, and
- •either having failed autologous HSCT, or being ineligible for or not
- •consenting to autologous HSCT
- •4) Measurable disease at time of enrollment
- •5) Life expectancy *12 weeks
- •6) ECOG performance status that is either 0 or 1 at screening
- •7) Adequate organ function:
- •- Renal function defined as: A serum creatinine of *1.5 x ULN OR eGFR
- •* 60 mL/min/1.73 m2
- •- Liver function defined as:
- •* ALT * 5 times the ULN for age
- •* Bilirubin * 2.0 mg/dl with the exception of patients with Gilbert*
- •Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome
- •may be included if their total bilirubin is * 3.0 x ULN and
- •direct bilirubin * 1.5 x ULN . Must have a minimum level of
- •pulmonary reserve defined as * Grade 1 dyspnea and
- •pulse oxygenation > 91% on room air . Hemodynamically
- •stable and LVEF * 45% confirmed by echocardiogram or
- •- Adequate bone marrow reserve without transfusions defined as:
- •* Absolute neutrophil count (ANC) > 1.000/mm3
- •* Absolute lymphocyte count (ALC) * 300/mm3
- •* Platelets * 50.000//mm3
- •* Hemoglobin > 8.0 mg/dl .
- •8) Must have an apheresis product of non-mobilized cells accepted for
- •manufacturing .
- •9) Women of child-bearing potential (defined as all women
- •physiologically capable of becoming pregnant) and all male participants
- •must agree to use highly effective methods of contraception for at least 12
- •following CD19 CART infusion and untill CAR-T cells are no longer present by
- •PCR on two consecutive tests.
排除标准
- •1) Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any
- •other anti-CD19 therapy
- •2) Treatment with any prior gene therapy product
- •3) Active CNS involvement by malignancy
- •4) Prior allogeneic HSCT
- •5) Eligible for and concenting to autologus HSCT
- •6) Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of
- •7) Investigational medicinal product within the last 30 days prior to screening
- •Note: Investigational therapies must not be used at any time while on study
- •until the first
- •progression following CTL019 infusion.
- •8) The following medications are excluded:
- •* Steroids: Therapeutic doses of steroids must be stopped > 72 hours
- •prior to prior to leukapheresis and > 72 hours CTL019 infusion. However, the
- •following physiological
- •replacement doses of steroids are allowed: <6 * 12 mg/m2/day
- •hydrocortisone or equivalent
- •* Immunosuppression: Any immunosuppressive medication must be
- •stopped * 2 weeks prior to leukapheresis and * 2 weeks prior to CTL019 infusion.
- •* Antiproliferative therapies other than lymphodepleting chemotherapy within 2
- •weeks of leukapheresis and 2 weeks prior to infusion
- •* Antibody use including anti-CD20 therapy within 4 weeks prior to
- •enrollment or 5 halflives of the respected antibody, whichever is longer
- •* CNS disease prophylaxis must be stopped > 1 week prior to
- •CTL019 infusion (e.g. intrathecal methotrexate)
- •9) Prior radiation therapy within 2 weeks of enrollment
- •10) Active replication of or prior infection with latent hepatitis B or active
- •hepatitis C
- •11) HIV positive patients
- •12) Uncontrolled acute life threatening bacterial, viral or fungal infection
- •(e.g. blood culture positive * 72 hours prior to infusion)
- •13) Unstable angina and/or myocardial infarction within 6
- •months prior to screening
- •14) Previous or concurrent malignancy with the following exceptions:
- •* Adequately treated basal cell or squamous cell carcinoma (adequate
- •wound healing is required prior to study entry)
- •* In situ carcinoma of the cervix or breast, treated curatively and
- •without evidence of recurrence for at least 3 years prior to the study
- •* A primary malignancy which has been completely resected and in complete
- •remission more than 5 years
研究者
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