JPRN-UMIN000030143已完成1 期
Phase 1/2 study of adoptive cell therapy using cultured tumor infiltrating lymphocytes with lympho-depleting non-myeloablative preconditioning for patients with advanced melanoma - MM-TIL-P1/2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
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 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Have experienced non-myeloablative lymphocyte depleting preparative regimen or myeloablative lymphocyte depleting preparative regimen. 2) Have central nervous system infiltration that causes symptoms. 3) Subjects with intraocular melanoma. 4) Women who are pregnant or breastfeeding. 5) Subjects who take immunosuppressant drugs or adrenocortical steroid*. (*Excluding subjects who had adrenal insufficiency due to anti-PD1 or anti-CTLA4 antibodies therapy, which need steroid replacement dose) 6) Have active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system. 7) Have active other multiple primary malignancies. 8) Have active autoimmune disease. 9) Have a history of severe allergy to cyclophosphamide, fludarabine and IL-2. 10) Left ventricular ejection fraction (LVEF) <=50% 11) Forced expiratory volume in 1 second (FEV1.0%)<=60% 12) Has known history of HBV, HCV, HTLV-1, HIV. 13) Be determined to be ineligible by doctors.
研究者
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