CARPALL: Immunotherapy With CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorUniversity College, London

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

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators