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WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
Bu çalışma, lösemi (leukaemia) tedavisinde WT1 TCR-transdükte T hücreleri adı verilen bir gen terapisinin güvenliliğini ve yan etkilerini incelemektedir. Bu tedavide hastanın kendi T hücreleri, WT1 hedefli bir T hücre reseptörü taşıyacak şekilde laboratuvarda değiştirilir. Çalışmaya 18-75 yaş arası, HLA A*0201 pozitif hastalar alınmış ve çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
General Inclusion Criteria: * Age ≥ 18 years and ≤ 75 years. * Life expectancy ≥ 16 weeks (4 months). * World Health Organisation (WHO) performance status of 0-2 * HLA A\*0201 positive * Completed previous course of chemotherapy ≥ 4 weeks prior to commencing the initial phase of the trial (leucapheresis for collection of patient PBMC). * Peripheral blood total lymphocyte count \> 0.5x109/L. * Informed consent in writing and ability to co-operate with treatment and follow up. * Willing, able and available for collection of PBMC/ T cells by leucapheresis. * Hepatitis B and C, HTLV-1, Syphilis, HIV negative. * Free from serious concurrent illness. * 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. * Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards. * 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 Further disease specific inclusion criteria are detailed in Protocol Exclusion Criteria: * Age \< 18 years or \> 75 years. * Patients should not receive concurrent systemic corticosteroids whilst on the study. * Within three months of having received fludarabine (at time of leucapheresis). * Major thoracic and/or abdominal surgery in the preceding three to four weeks from which the patient has not yet recovered. * Patients who are high medical risks because of non-malignant systemic disease, as well as those with active uncontrolled infection. * Patients with any other condition, which in the Investigator's opinion would not make the patient a good candidate for the clinical trial. * Patients known to be serologically positive for Hepatitis B, C, HTLV-1 Syphilis or HIV. * Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease * Positive pregnancy test or reluctance to use contraception. * Pregnant and lactating women are excluded. * History of Severe Allergy.