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) -

OVARTIS FARMA S.P.A.0 个研究点目标入组 100 人开始时间: 2021年5月24日最近更新: 2021年8月17日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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

•1) Written informed consent must be obtained prior to any screening procedures
•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 MUGA .
•- Adequate bone marrow reserve defined as:
•Absolute neutrophil count (ANC) > 1.000/mm3
•Absolute lymphocyte count (ALC) = 300/mm3
•Platelets = 50.000//mm3
•Hemoglobin > 8.0 g/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 months following CTL019 infusion and until CAR T cells are no longer present by PCR on two consecutive tests
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

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 consenting to autologous HSCT
•6) Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion
•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 leukapheresis and > 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: < 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. This could include check point inhibitors (monoclonal antibodies and small molecule modulators).
•Antiproliferative therapies other than lymphodepleting chemotherapy within two weeks of leukapheresis and 2 weeks prior to infusion
•- Short acting drugs used to treat leukemia or lymphoma (e.g. tyrosine kinase inhibitors, and hydroxyurea) must be stopped > 72 hour prior to leukapheresis and > 72 hours prior to CTL019 infusion
•- Other cytotoxic drugs, including low dose daily or weekly maintenance chemotherapy, must not be given within 2 weeks prior to leukapheresis and within 2 weeks prior to CTL019 infusion.
•- Fludarabine may be associated with prolonged lymphopenia. This should be taken into consideration when evaluating the optimal timing for leukapheresis.
•Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 halflives of the respective 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 infusion
•10) Active replication of or prior infection with latent hepatitis B or active hepatitis C (HCV RNA positive)
•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 for = 5 year
•15) Pregnant or nursing (lactating) women
•16) Intolerance to the excipients of the CTL019 cell product
•17) Cardiac arrhythmia not controlled with medical management
•18) Removed
•19) Prior treatment with any adoptive T cell therapy
•20) Patients with active neurological auto immune or inflammatory disorders (e.g. Guillain-Barré Syndrome, Amyotrophic Lateral Sclerosis)

研究者

发起方

OVARTIS FARMA S.P.A.

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