Gene-Edited super cells take on childhood leukemia

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients * Age ranging between 6 months and \<16 years Medical and therapeutic criteria * Relapsed AML ahead of scheduled allogeneic haematopoietic stem cell transplantation (allo-SCT). * Morphologically confirmed with leukemic blasts in the bone marrow (\>5%) or a quantifiable MRD by multiparameter flow cytometry and/or quantitative polymerase chain reaction (\>10-4) * CD33+ leukaemia associated immunophenotype (LAIP) on \>95% of blasts * Eligible and fit for allogeneic hematopoietic stem cells transplantation with suitable donor available * Estimated life expectancy ≥ 12 weeks * Lansky (age \< 16 years at the time of assent/consent) or performance status ≥ 70; * Eastern Cooperative Oncology Group ECOG performance status \< 2. Exclusion Criteria: * Patients/parents unwilling to undergo follow-up for 15 years * Foreseeable poor compliance to the study procedures * Evidence of disease progression after cytoreduction * Uncontrollable CNS leukaemia or neurological symptoms defined as CNS grade 3 (per * National Comprehensive Cancer Network guidelines) * Absence of suitable HLA matched or mismatched donor * Weight \< 6kgs * Presence of donor-specific anti-HLA antibodies directed against BE-CAR33 * GvHD requiring systemic therapy * Systemic steroid therapy prednisolone \>0.5mg/kg/day * Known hypersensitivity to test materials or related compounds * Active bacterial, fungal or viral infections not controlled by standard of care anti- microbial or anti-viral treatment. Uncontrolled bacteraemia/ fungaemia is defined as the ongoing detection of bacteria/fungus on blood cultures despite antibiotic or anti-fungal therapy. Uncontrolled viraemia is defined as rising viral loads on two consecutive occasions despite antiviral therapy. * Risk of pregnancy or non-compliance with contraception (if applicable). Girls of childbearing potential must have been tested negative in a pregnancy test within 14 days prior to inclusion. * Lactating female participants unwilling to stop breastfeeding * Prior CAR T cell therapy known to be associated with ≥Grade 3 cytokine release syndrome (CRS) or ≥Grade 3 drug-related CNS toxicity