The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).
Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of > 95% on room air
Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening
Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening
Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening
Failure to meet any of the inclusion criteria
Patients who test positive on urine pregnancy testing and are pregnant or are lactating
Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome
Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease