WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study

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