Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma

Key Inclusion Criteria:

• Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy
• CCR9-positive disease as assessed by flow cytometry
• T-LBL patients only: Patients must have measurable disease
• Agreement to have a pregnancy test, use adequate contraception (if applicable)
• Written informed consent

Key Exclusion Criteria:

• ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old)
• Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
• Active CNS involvement of disease
• Active hepatitis B, C or HIV infection
• Oxygen saturation ≤90% on air
• Bilirubin >3 x upper limit of normal
• GFR <30 ml/min
• Cardiac dysfunction
• Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
• Known allergy to any component of the ATIMP
• Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC
• Women who are pregnant or breastfeeding
• Life expectancy <3 months
• Fulminant or rapidly progressive disease