About this trial
This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
Eligibility criteria
Qualifiers
Resistant disease (>5% blasts) at end of ALLTogether-1 protocol or equivalent induction
ALL with persisting high level MRD at 2nd time point of frontline national protocol (currently MRD >10-4 at week 9 ALLTogether-1 Protocol or equivalent).
High risk infant ALL (age < 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count > 300 x 10^9/L or poor steroid early response (i.e. circulating blast count >1x10^9/L following 7 day steroid pre-phase of induction as per national guidelines or equivalent)
Any patient with t(17,19) TCF3-HLF rearrangement
Disqualifiers
Active Hepatitis B, C or HIV infection
Oxygen saturation ≤ 90% on air
Bilirubin > 3 x upper limit of normal
Creatinine > 3 x upper limit of normal
Trial design
Treatments tested in this trial
- Leukapheresis
- Total Body Irradiation (TBI)
- Lymphodepletion with Fludarabine
- Lymphodepletion with Cyclophosphamide
- CD19+CD22 CAR T-cells