EUCTR2018-001404-11-IT进行中（未招募）1 期
A phase I/IIa dose escalation study evaluating the safety and efficacy of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-a2 in patients with glioblastoma multiforme who have an unmethylated O-6- methylguanine-DNA methyltransferase gene promoter - TEM-GBM
GENENTA SCIENCE SR0 个研究点目标入组 21 人开始时间: 2019年6月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
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
- •Inclusion Criteria at Screening:
- •Patients aged between 18 and =70.
- •Histologically confirmed, newly diagnosed supratentorial
- •glioblastoma with unmethylated MGMT gene promoter.
- •Patients have undergone complete or partial tumor resection.
- •Able and willing to provide written informed consent and comply with the study protocol and procedures. • Eligible for radiotherapy.
- •Life expectancy of 6 months or more at Screening.
- •Women of child-bearing potential enrolled in the study must
- •have a negative pregnancy test at screening and agree to use
- •acceptable methods of contraception during the trial.
- •Men enrolled in the study with partners who are women of
- •child-bearing potential, must be willing to use an acceptable
- •barrier contraceptive method during the trial or have undergone
- •successful vasectomy at least 6 months prior to entry into the
- •study. Successful vasectomy needs to have been confirmed by
- •semen analysis.
- •Karnofsky performance score (KPS)=70.
- •Additional inclusion criteria to be assessed within 20 days of Temferon administration:
- •Adequate cardiac, renal, hepatic and pulmonary function as evidenced by:
- •o Left ventricular ejection fraction (LVEF) = 45% by echo and normal electrocardiogram (ECG) or presence of abnormalities not significant for cardiac disease.
- •Absence of severe pulmonary hypertension;
- •o Diffusing capacity of the lung for carbon monoxide (DLCO) >50% and forced expiratory volume in 1 sec (FEV1) and forced expiratory vital capacity (FVC) >60% predicted (if non cooperative: pulse oximetry > 95% in room air);
- •o Serum creatinine < 2x upper limit normal and estimated
- •glomerular filtration rate (eGFR) = 30ml/min/1.73m^2;
- •o Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2.5 x upper limit of normal (ULN), and total bilirubin = 2.0 mg/dl.
- •o Hemoglobin =10 g/dL, platelet count =100000/mm^3,
- •absolute neutrophil count >1500/mm^3.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Use of other investigational agents or procedures within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents) or participation in a previous gene therapy study.
- •Known hypersensitivity to carmustine (or any other nitrosurea), thiotepa, lenograstim, plerixafor, or any excipients used in these products.
- •Receipt of any oral or parenteral chemotherapy or immunotherapy within 2 years of Screening. •Previous allogeneic bone marrow transplantation, kidney or liver transplant.
- •Clinical evidence of persistent raised intracranial pressure following surgical resection. •Clinically relevant active viral, bacterial, or fungal infection at eligibility evaluation.
- •Active autoimmune disease or a relevant history of important autoimmune manifestations, in particular psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis, vasculitis, immune-mediated peripheral neuropathies.
- •History of sarcoidosis.
- •History or current evidence of neuropsychiatric illness including depression, schizophrenia, bipolar disorders, impaired cognitive function, dementia or suicidal tendency.
- •History of severe cardiovascular disease such as prior stroke, coronary artery disease requiring intervention or unresolved arrhythmias in the past 6 months.
- •Evidence of any hematological neoplasm.
- •Positivity for human immunodeficiency virus type 1 or 2 (HIV-1, HIV-2) (serology or RNA), and/or Hepatitis B Virus Surface Antigen (HbsAg) and/or Hepatitis B Virus (HBV) DNA and/or Hepatitis C virus (HCV) RNA (or negative HCV RNA but on antiviral treatment) and/or Treponema Pallidum or Mycoplasma active infection.
- •Active alcohol or substance abuse within 6 months of the study.
- •Current pregnancy or lactation.
- •Known bleeding diathesis or history of abnormal bleeding, or any other known coagulation abnormalities that would contraindicate lumbar puncture for CSF or future surgery.
- •Use of immunosuppressants with the exception of steroids. The maximum permitted dexamethasone (or equivalent) dose is 4 mg per day.
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