An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia.

Other illness

• Presence of CNS 3 disease or CNS 2 disease with neurological changes
• Active or latent Hepatitis B or active Hepatitis C.

Other

• Diagnosis of Burkitt’s leukaemia/lymphoma according to World Health Organisation (WHO) classification or chronic myelogenous leukaemia lymphoid in blast crisis.
• History or presence of clinically relevant CNS pathology

• Age 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Relapsed or refractory CD19-positive B-ALL
• Patients with Philadelphia chromosome positive ALL (Ph+ ALL) are eligible if they are intolerant to or have failed two lines of any tyrosine kinase inhibitor (TKI) or one line of second-generation TKI, or if TKI therapy is contraindicated.
• In patients treated with blinatumomab, CD19 expression should be confirmed after blinatumomab therapy has been stopped.
• Adequate renal, hepatic, pulmonary, and cardiac function