CD19-targeting 3rd generation CAR T cells for refractory B cell malignancy - a phase I/IIa trial. - 003:TCE

ppsala university0 个研究点目标入组 30 人开始时间: 2013年8月12日最近更新: 2017年11月13日

适应症

试验速览

暂无简介。

•Patients may be included in the study only if they meet all of the following criteria:
•1)Relapsed or refractory CD19+ B-cell lymphoma or leukemia
•2)Measurable disease.
•3)Performance status ECOG 0-2.
•4)>18 years old.
•5)Fertile females/males must consent to use contraceptives during participation of the trial.
•6)Adequate bone marrow, renal, hepatic and cardiovascular function.
•7)Signed informed consent.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•The presence of any of the following criteria will exclude the patient from participating in the study:
•1.Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
•2.Patients with primary CNS lymphoma.
•3.Known human immunodeficiency virus (HIV) infection.
•4.Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
•5.Other serious underlying medical conditions, which, in the Investigator’s judgment, could impair the ability of the patient.
•6.Treatment with an investigational product within 30 days prior to enrolment.
•7.Patients that do not consent to that tissue and blood samples are stored in a biobank.
•8.Pregnancy

发起方

ppsala university