The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).
Patients who are unable to tolerate standard chemotherapy due to significant toxicity as well as other comorbidities
Minimum level of pulmonary reserve defined as grade ≤ 1 dyspnoea and oxygen saturation of > 95% on room air
Left ventricular systolic function ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction ≥ 45% confirmed by echocardiogram within 3 months of screening
Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at 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 BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM 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