JPRN-jRCT2080222504已完成1 期
Multi-center, Investigator Initiated Phase 1 Study of MAGE-A4 Specific TCR Gene Transduced T Lymphocytes Transfer for Patients with Solid Tumors
Mie University, Aichi Medical University, National Cancer Center Hospital, National Cancer Center Hospital East, Nagoya Medical Center, Keio University0 个研究点目标入组 12 人开始时间: 2014年5月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically or cytologically confirmed solid tumors
- •2) Solid tumor, which is unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc.)
- •3) HLA-A*24:02 positive
- •4) MAGE-A4-expression by PCR or immunohistochemistry
- •5) ECOG Performance Status, 0 or 1
- •6) Age >=20 years on consent
- •7) No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer.
- •8) Life expectancy >= 16 weeks after consent
- •9) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria:
- •WBC >= 2,500/mm^3
- •Hemoglobin >= 8.0g/dL
- •Platelets >= 75,000/mm^3
- •T. billirubin < 1.5 x ULN
- •AST(GOT), ALT(GPT) < 3.0 x ULN
- •Creatinine < 1.5 x ULN
- •10) Ability to understand the study contents and to give a written consent at his/her free will.
排除标准
- •1) The following serious complications are excluded from the study;
- •Unstable angina, cardiac infarction, or heart failure
- •Uncontrolled diabetes or hypertension
- •Active infection
- •Obvious interstitial pneumonia or lung fibrosis by chest X-ray
- •Active autoimmune disease requiring steroids or immunosuppressive therapy
- •2) Serious hypersensitivity
- •3) Tumor cell invasion into CNS
- •4) Active multiple cancer
- •5) Positive for HBs antigen or HBV-DNA observed in serum, or positive for HCV antibody and HCV-RNA observed in serum
- •6) Positive for antibodies against HIV or HTLV-1
- •7) Left Ventricular Ejection Fraction (LVEF): <= 50%
- •8) Percutaneous Oxygen saturation: < 94%
- •9) History of hypersensitivity reactions to bovine, murine, or equine derived substances.
- •10) History of hypersensitivity reaction to drugs used in this study
- •11) Psycological disorder or drug dependency which may have impact on the consent.
- •12) Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control after the consent during the study
- •13) Clinically significant systemic illness that in the judgment of the PI or subinvestigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.
研究者
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