WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study (WT1 TCR-001)
- 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
- 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
- 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
- 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.