JPRN-UMIN000017748招募中1 期
A phase Ia /Ib study of vaccination with NY-ESO-1 protein, Poly ICLC and mogamulizumab in patients with Adult T cell leukemia/lymphoma expressing NY-ESO-1 antigen - A clinical study of combination therapy with NY-ESO-1 vaccine and mogamulizumab for AT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 89years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Severe underlying diseases. 2. The patient has at least one clinical laboratory value as follows: 1) Absolute neutrophil count <1.500/mm3 2) Hemoglobin <8.0g/dL (blood transfusion is acceptable) 3) Platelet count < 50,000/mm3 4) Serum total bilirubin>1.5*ULN (except for patient with Gilberts syndrome for whom the limit is 2*ULN) 5) AST> 2*ULN (upper limit of normal) and ALT> 2*ULN 6) Serum creatinine > 1.5*ULN 7) Corrected Serum calcium > 11mg/dL 8) Percutaneous arterial oxygen saturation by pulse oximetry (SpO2) < 90% 3. Positive for HCV antibody, HIV. 4. Positive for HBs antigen or HBs antibody or HBc antibody, and HBV-DNA is over the limit of quantification. 5. Other malignancies within 5 years. 6. Needs treatment with corticosteroids, or any other immunosuppressive agents. 7. Any autoimmune disease. 8. Any history of severe hypersensitivity. 9. Any active infectious complication. 10. Uncontrolled bleeding disorder. 11. Pregnant or lactating. 12. Investigator considers to be inappropriate to participate in this study.
研究者
相似试验
已完成
1 期
A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigePatients with NY-ESO-1-expressing advanced esophageal cancer, gastric cancer, lung cancer and malignant melanomaJPRN-UMIN000007954Gastroenterological Surgery Osaka University Graduate School of Medicine15
已完成
1 期
A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigeJPRN-UMIN000001857Department of Immunology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences9
已完成
1 期
Immunization With NY-ESO-1 Protein Combined With CpG 7909 in Patients With Prostate CancerProstate CancerNCT00292045Ludwig Institute for Cancer Research15
终止
1 期
NY-ESO-1 Vaccine in Combination With Ipilimumab in Patients With Unresectable or Metastatic MelanomaUnresectable or Metastatic MelanomaNCT01810016Ludwig Institute for Cancer Research8
招募中
1 期
Phase 1/2 study of recombinant vaccinia-NY-ESO-1 (rV-NY-ESO-1) and recombinant fowlpox-NY-ESO-1 (rF-NY-ESO-1) in patients with NY-ESO-1 or LAGE positive cancersC80Malignant neoplasm, without specification of siteDRKS00000194Krankenhaus Nordwest 2. Medizinische Klinik60