EUCTR2016-004043-36-SE进行中（未招募）1 期
CD19-TARGETING 3RD GENERATION CAR T CELLS FOR REFRACTORY B CELL MALIGNANCY – A PHASE II TRIAL - 004:TCE
ppsala University0 个研究点目标入组 25 人开始时间: 2017年1月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
入选标准
- •1.Relapsed or refractory CD19+ B-cell lymphoma, leukemia or Hodgkin lymphoma with no other curative treatment option available.
- •2.Measurable disease
- •3.All ages
- •4.Performance status ECOG 0-2 (Appendix IV)
- •5.Fertile females/male must consent to use highly effective* contraceptives during the participation of the trial
- •6.Signed informed consent
- •* This study follows the 2014 CTFG guidance document Recommendations related to contraception and pregnancy testing in clinical trials” (Appendix XII). The patients must consent to use highly effective contraceptives during the participation of the trial. Contraceptive methods considered highly effective by the guidance document are those with a Pearl index <1% when used consistently and correctly. Highly effective contraceptives include combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation via e.g. oral, transdermal or intravaginal administration. Also included are progesterone-only hormonal contraception associated with inhibition of ovulation via e.g. oral, injectable or implantable administration. Other acceptable methods include intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner and sexual abstinence. Methods not included are e.g. condoms, diaphragm with spermicide and low-dose progesterone.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •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 to perform the treatment
- •6.Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half-lives of that drug, which is longest
- •7.Pregnancy
- •8.Patients that do not consent to that tissue and blood samples are stored in a biobank
- •9.Patients whose cells cannot be manufactured
研究者
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