EUCTR2012-005327-33-GB进行中（未招募）1 期
A Phase II Trial to Assess the Activity of NY-ESO-1 Targeted T Cells in Advanced Oesophagogastric Cancer - Phase II Trial of NY-ESO-1 Targeted T Cells in Oesophagogastric Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Pre-screening:
- •Patients must be HLA-A0201 positive on pre-screen blood test
- •If confirmed HLA-A0201 positive, subjects tumour sample must stain positive by immunohistochemistry for NY-ESO-1 and/or LAGE (either diagnostic or more recent biopsy is acceptable. Subject may require additional biopsy if insufficient tumour material available form diagnostic sample).
- •Main Study:
- •Patients must have histologically confirmed oesophagogastric cancer and have received prior chemotherapy.
- •Confirmed evidence of measurable metastatic disease (by RECISTv1.1)
- •Patients may have had any previous systemic therapies provided they are otherwise fit for treatment
- •Age equal to or greater than 18 years
- •World Health Organisation (WHO) performance status of 0 or 1
- •Life expectancy >3months
- •LVEF > 50% as measured by ECHO or MUGA
- •Haematological and biochemical indices:
- •(i) Haemoglobin (Hb) = 80 g/L
- •(ii) Neutrophils = 1.0 x 109/L
- •(iii) Platelets (Plts) = 100 x 109/L
- •Any of the following abnormal baseline liver function tests:
- •(i) serum bilirubin 1.5 x ULN
- •(ii) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 5 x ULN and/or Serum creatinine = 150 µmol/L or creatinine clearance > 50 ml/min.
- •These measurements must be performed prior to leukaphereses and again prior to commencing preconditioning chemotherapy.
- •The chemotherapy to be used in this trial is non-myeloablative, but where there is concern about a patient’s bone marrow reserves, for example due to multiple previous lines of myelosuppressive chemotherapy a backup stem cell harvest should also be obtained.
- •Female patients of child-bearing potential must have a negative serum or urine pregnancy test prior to treatment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial, and for six months afterwards.
- •Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.
- •Full written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •Those receiving radiotherapy, biological therapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment.
- •All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities, which an investigator considers should not exclude the patient.
- •Participation in any other clinical trial within the previous 30 days or during the course of this treatment.
- •Previous allogeneic transplant.
- •Clinically significant cardiac disease. Examples would include unstable coronary artery disease, myocardial infarction within 6 months or Class III or IV AHA criteria for heart disease
- •Patients who are high medical risks because of non-malignant systemic disease, including those with, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the lead clinicians opinion would not make the patient a good candidate for adoptive T-cell therapy
- •Concurrent systemic infections (CTCAE Grade 3 or more) within the 28 days prior to treatment.
- •Prior history of malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
- •Patients known or found to be serologically positive for Hepatitis B, C, HIV or HTLV.
- •History of systemic autoimmune disease which could be life-threatening if reactivation occurred (for example hypothyroidism would be permissible, prior rheumatoid arthritis or SLE would not).
- •Evidence of CNS involvement.
- •Patients who are likely to require systemic steroids or other immunosuppressive therapy.
- •Pregnant and lactating women.
- •Radiotherapy to >25% skeleton.
研究者
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