ISRCTN26113637已完成不适用
Adaptive study of the safety, tolerability & efficacy of autologous ?d T lymphocyte therapy (ImmuniCell®) in patients with advanced cancers refractory to current treatment or have indolent disease for which immunotherapy may be beneficial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- TC BioPharm
- 入组人数
- 48
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
- 性别
- All
入选标准
- •1. Male or female patients aged =18 years
- •2. Performance status ECOG 0 or 1
- •3. Subjects with histological or cytological confirmation of advanced metastatic melanoma, renal cell carcinoma or NSCLC which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial
- •4. Measurable disease according to the irRC criteria
- •5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to Cycle 1:
- •5.1. Creatinine = 1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance = 50 ml/min
- •5.2. Total bilirubin = 1.5 x ULN
- •5.3. Alanine transaminase (ALT) and aspartate transaminase (AST) = 2.5 x ULN or = 5 x ULN with liver metastases
- •5.4. White blood cell count =3.0 x 109/L
- •5.5. Absolute Neutrophil Count (ANC) =1.5 x 109/L
- •5.6. Platelets =100 x 109/L
- •5.7. Haemoglobin = 10 g/dL
- •6. Life expectancy of at least 3 months
- •7. Sufficient evidence of ?d T lymphocytes expansion in the proliferation assay at the first screening visit which will be a population doubling of ?d T lymphocytes = 1.0 between 48-96 hours in culture.
- •8. Able to give informed, written consent
- •9. For female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine pregnancy test at screening and must not be breastfeeding.
排除标准
- •1. Other primary cancers apart from non-melanoma skin cancers, carcinoma – in situ of the cervix, or a prior cancer treated with curative intent more than 5 years ago without any evidence or recurrent disease
- •2. Uncontrolled systemic infection
- •3. Systemic steroid therapy or other immunosuppressant’s
- •4. Treatment with bisphosphonates, for instance zoledronate, in the previous 30 days or throughout the trial
- •5. New York Heart Association (NYHA) functional class =3 (Appendix 4) or myocardial infarction within 6 months
- •6. Clinically significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy
- •7. Ulcerative Colitis / Inflammatory bowel disease, Addison’s disease
- •8. Pregnancy or lactation prior to or during the trial. A urine or serum pregnancy test will be carried out at screening
- •9. Taking any other IMP or participation in another interventional clinical trial in the previous 30 days
- •10. Less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and more than 6 weeks since mitomycin C and nitrosureas
- •11. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results
- •12. Any other condition considered by a trial physician to be inappropriate for inclusion.
- •13. Coagulation disorders - Contraindications should also be taken into consideration during the Leukapheresis procedure these include, contraindications to heparin which are: significant thrombocytopenia (platelet count less than 50x109/litre); recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of Type II heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder.
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