EUCTR2006-004950-25-GB进行中（未招募）1 期
WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study - WT1 TCR transduced autologous T cells
Cell Medica Ltd0 个研究点目标入组 18 人开始时间: 2008年11月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- •GENERAL INCLUSION CRITERIA
- •All patients will undergo detailed laboratory based assessment prior to the procedure (Appendix A3).
- •a) Age =18 years and =75 years.
- •b) Life expectancy =16 weeks (4 months).
- •c) World Health Organisation (WHO) performance status of 0-2
- •d) HLA A*0201 positive
- •e) Completed previous course of chemotherapy = 4 weeks prior to commencing the initial phase of the trial (leucapheresis for collection of patient PBMC).
- •f) Peripheral blood total lymphocyte count >0.5x109/L.
- •g) Informed consent in writing and ability to co-operate with treatment and follow up.
- •h) Willing, able and available for collection of PBMC/ T cells by leucapheresis.
- •i) Hepatitis B and C, HTLV-1, Syphilis and HIV negative.
- •j) Free from serious concurrent illness.
- •k) Female patients of child-bearing age must have a negative pregnancy test and agree to use reliable contraceptive methods for the duration of the therapy and for 6 months afterwards.
- •l) Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards.
- •m) Haematological and Biochemical Indices:
- •-Haemoglobin (Hb) = 7.0 g/dl; neutrophils = 0.2 x 109/L; total lymphocytes >0.5 x 109/L; platelets (Plts) = 40 x 109/L
- •-serum bilirubin, Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 3 x upper normal limit
- •-calculated creatinine clearance = 30 ml/min (uncorrected value) or isotope clearance measurement = 30ml/min
- •DISEASE-SPECIFIC INCLUSION CRITERIA
- •AML or CML proven by morphology, histology, immunophenotyping and cytogenetics (where available).
- •ACUTE MYELOID LEUKAEMIA (AML):
- •(1) Patients NOT eligible for BMT procedure with:
- •(a) AML in 2nd CR or greater;
- •(b) Good and Standard Risk* AML in 1st CR or PR in patients >60 years; and
- •(c) Poor Risk* AML in 1st CR (slow remitters and/or adverse cytogenetics).
- •(2) AML at 1st relapse post BMT in CR or PR after re-induction and consolidation.
- •[NB, *risk category as defined by MRC criteria: Good Risk: t(15;17), t(8;21), inv 16; Poor Risk: -5; -7; del (5q); abn (3q) or complex (=/>4 abn)].
- •CHRONIC MYELOID LEUKAEMIA (CML):
- •1. Patients in chronic phase resistant to Glivec/Imatinib and 2nd generation tyrosine kinase inhibitors (eg., Dasatinib), AND NOT eligible for allogeneic BMT.
- •2. Patients in chronic phase resistant to Glivec/Imatinib and with an identified mutation known to be resistant to 2nd generation tyrosine kinase inhibitors, AND NOT eligible for allogeneic BMT.
- •3. Patients = 50 years (and ineligible for myeloablative allo BMT), with a suboptimal response to Glivec/Imatinib and an identified mutation known to be resistant to 2nd generation tyrosine kinase inhibitors. These patients are at high risk of disease progression. Patients in this group would stop Glivec/Imatinib prior to leucapheresis and receiving TCR-transduced T cells. They will have monthly quantitative RT-PCR for Bcr-Abl and restart Glivec/Imatinib in the event of a log increase in transcript numbers.
排除标准
- •EXCLUSION CRITERIA
- •a) Age <18 years or >75 years.
- •b) Patients should not receive concurrent systemic corticosteroids whilst on the study.
- •c) Within three months of having received fludarabine (at time of leucapheresis).
- •d) Major thoracic and/or abdominal surgery in the preceding three to four weeks from which the patient has not yet recovered.
- •e) Patients who are high medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection.
- •f) Patients with any other condition, which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
- •g) Patients known to be serologically positive for Hepatitis B, C, HTLV-1, Syphilis or HIV.
- •h) Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease
- •i) Positive pregnancy test or reluctance to use contraception.
- •j) Pregnant and lactating women are excluded.
- •k) History of Severe Allergy.
研究者
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