NCT01947569Unknown1 期
Autologous Co-stimulation-impaired Dendritic Cells for Type 1 Diabetes Mellitus (T1DM) Therapy: A Sequential Open Label Phase IB Safety Assessment/ Randomized, Double-blind Phase IIA Efficacy Trial to Maintain and Improve Functional Beta Cell Mass in New Onset Disease T1DM Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The incidence of treatment-emergent adverse events.
研究概览
简要总结
Phase IB will evaluate the safety of autologous, ex vivo-engineered, co-stimulation impaired dendtritic cells to maintain and improve functional residual beta cell mass in new onset Type I Diabetes Mellitus (T1DM) patients. Efficacy measures will be collected and summarized.
Phase IIA will evaluate the safety and efficacy of 3 randomized treatment groups in new onset T1DM patients to assess if the antisense DNA-treated co-stimulation-impaired immunoregulatory dendritic cells (iDC) will safely preserve and/or increase B-cell mass resulting in improvement and/or normalization of blood glucose levels and glycated hemoglobin A1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(both open label phase IB safety and Phase IIA study):
- •Patients with new onset T1DM (>18 years of age for the phase IB and then >16 (first 10 subjects), >12 years of age for the second 10 subjects, > 8 years for the next 10 subjects and, finally, >8 years of age for the remainder of the phase IIA patients) within 6 months of diabetes mellitus diagnosis.
- •Evidence of decreased β-cell function as measured by C-peptide and blood glucose levels consistent with impaired glucose tolerance.
- •Evidence of at least one high-risk HLA haplotype.
- •Evidence of at least one diabetes-related autoantibody (e.g. IA-2, GAD, ZnT8) ,
- •Adequate immune competence as assessed by immunoreactivity to alloantigens in mixed leukocyte culture and reactivity to viral antigens (CEF Pool Assay) in vitro.
- •Normal hematologic, liver and kidney function.
- •Female participants of childbearing potential in this study must agree to use an effective form of birth control during study participation. Reliable and effective forms of birth control include: true abstinence, intrauterine device (IUD), hormonal-based contraception, double-barrier contraception [condom or occlusive cap (diaphragm or cervical cap) with spermicide], or surgical sterilization (vasectomy for male partner, tubal ligation or hysterectomy). Sexually active male participants must agree to use an effective form of birth control such as condoms.
排除标准
- •(both open label phase IB safety and Phase IIA study):
- •Enrollment or history of enrollment in a drug, or biologic therapy study sponsored by TrialNet.
- •A significant history or current evidence of cardiac disease, uncontrolled hypertension, serious arrhythmias.
- •Evidence of active infection requiring antibiotic therapy.
- •History of other concurrent significant medical diseases.
- •Pregnant or lactating women.
- •Patients requiring chronic systemic corticosteroids.
- •Any other immune disorder including but not limited to other autoimmune diseases, HIV, HBV, HCV, HPV, HSV positivity.
- •Impaired renal function with a creatinine level > 1.
- •Administration of the following therapies while patients are undergoing treatment on this protocol: i) radiation therapy; ii) chemotherapy; iii) corticosteroids (except when administered in life-threatening circumstances); iv) other particle or cell-based therapies; v) other biologic therapies; vi) other therapies aimed at modulating the immune system; vii) other endocrine-related therapies, hormone replacement (other than thyroxine and contraceptive), glucoregulation.
- •A hemaglobinopathy known to interfere with the ability to accurately determine HbA1c.
- •No prior radiation therapy, immunotherapy, or chemotherapy.
研究组 & 干预措施
Placebo recipients
Placebo Comparator
Saline injections.
干预措施: Biological (Biological)
iDC recipients
Experimental
iDC cells modified by in vitro engineering.
干预措施: Biological (Biological)
Control DC recipients
Active Comparator
DC cells which have not been modified.
干预措施: Biological (Biological)
结局指标
主要结局
The incidence of treatment-emergent adverse events.
时间窗: Month 12
次要结局
- 2-hour area under the curve (AUC) average of C-peptide at 12 months after completion of administration of assigned therapy (Protocol Month 15).(12 Months)
研究者
研究点 (1)
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