Key inclusion criteria:
1. Relapsed or refractory T-ALL/ T-LBL following at least:
• Patients ≥18 years old: 1 standard prior line of combination cytotoxic therapy
• Patients
2. CCR9-positive disease as assessed by flow cytometry.
3. T-LBL patients only: Patients must have measurable disease which is CCR9-positive by standard flow cytometry tests (on tissue biopsy, blood, bone marrow, or malignant effusion).
4. Agreement to have a pregnancy test, use adequate contraception (if applicable)
5. Written informed consent
Key exclusion criteria:
1. ECOG performance score > 2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged
2. Stem Cell Transplant patients only: active significant acute GvHD (overall Grade ≥ II, modified Glucksberg criteria) or moderate/severe chronic GvHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids
3. Active CNS involvement of disease
4. Pre-existing neurological disorders unrelated to the malignancy, including, but not limited to, epilepsy, dementia, Parkinson’s disease, cerebellar disease, severe brain injuries, dementia, uncontrolled mental illness, and psychosis.
5. Active hepatitis B, C or HIV infection
6. Oxygen saturation ≤ 90% on air
7. Bilirubin >3 x upper limit of normal
8. GFR
9. Cardiac dysfunction as defined by:
• Patients ≥18 years old:
- cardiac dysrhythmias (excluding well-controlled atrial fibrillation or other supraventricular tachycardia) or
- significant cardiac disease (any of the following within six months prior to screening: myocardial infarction, unstable angina, stroke, and coronary bypass surgery) or
- left ventricular ejection fraction
• Patients
10. Active or significant gastrointestinal (GI) disorders (e.g. inflammatory bowel disease, recent bowel surgery).
11. Active autoimmune disease.
12. Receipt of any vaccination (including live attenuated vaccines) within 6 weeks prior to lymphodepletion.
13. Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
14. Known allergy to albumin, DMSO, PBS/EDTA (or any component of the ATIMP)
15. Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC
16. Women who are pregnant or breast feeding
17. Life expectancy
18. Fulminant or rapidly progressive disease