NCT02424916已完成1 期
Adoptive Transfer of CD8+ T Cells, Sorted With HLA-peptide Multimers and Specific for Melan-A and MELOE-1 Melanoma Antigens, to Metastatic Melanoma Patients. A Phase I/II, Non-randomized, Open Monocentric Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Clinical and biological safety defined by the NCI (Common Toxicity Criteria - Version 4.0, may 2009, http:// ctep.cancer.gov)
研究概览
简要总结
This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 and ≤ 75 years
- •Patient expressing the HLA-A*0201 subtype of the human leukocyte antigen (HLA -A2)
- •Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases
- •Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR
- •Absence of cerebral metastases
- •ECOG ≤ 1 or Karnofsky ≥ 80%
- •Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL... )
- •Disease measurable / evaluable within 28 days before the first administration of study treatment
- •Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis)
- •Results of analysis:
- •Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l
- •Leukocytes ≥ 4000/μl
- •Lymphocytes ≥ 1500/μl
- •Platelets ≥ 80.000/μl
- •Creatinine ≤ 2.5 N
- •Total bilirubin ≤ 3 N
- •AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases
- •Negative pregnancy test for women of childbearing age
- •Patient affiliated to a social security system
- •Patient who has signed informed consent
排除标准
- •Brain metastases
- •Ocular primitive melanoma
- •Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion
- •Treatment with ipilimumab within 8 weeks before the inclusion
- •Known allergy to albumin
- •Contraindication to the use of vasopressors
- •Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis
- •Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline
- •Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma)
- •History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction)
- •Uncontrolled thyroid dysfunction
- •Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study)
- •History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, ... ) with the exception of patients with active vitiligo or a history of vitiligo
- •History of uveitis and retinopathy associated with melanoma
- •Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
结局指标
主要结局
Clinical and biological safety defined by the NCI (Common Toxicity Criteria - Version 4.0, may 2009, http:// ctep.cancer.gov)
时间窗: Until disease progression during the follow-up period of the study (12 months)
Serious adverse effects of grade 3 and 4 will be considered to decide the suspension of inclusion
次要结局
- Overall survival(From the date of the first treatment until the date of death, assessed up to 2 years)
- Progression-free survival(From the date of the first treatment until the date of the first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years)
- Persistence of injected specific T cells evaluated by immunomonitoring(At 3 months)
- Overall tumor response (complete response, partial response, stable disease) evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST) and immune-related Response Criteria (irRC)(At 12 months)
- Duration of clinical responses defined as the time interval between the evaluation of the first objective response or stable disease and the first evaluation of disease progression(At 12 months)
研究者
研究点 (2)
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