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

This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells
engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with
relapsed or refractory B cell acute lymphoblastic leukemia (ALL).

Inclusion Criteria:

- Age 18 years or older Age 18 years or older

- ECOG performance status of 0 or 1

- Relapsed or refractory B cell ALL

- Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI,
or failed one line of second-generation TKI, or if TKI is contraindicated

- Documented CD19 positivity within 1 month of screening

- Phase Ib: Primary Cohort IA: Presence of ≥5% blasts in BM at screening

- Phase Ib: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and <5% blasts in the
BM at screening

- Phase II: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening

- Phase II: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central
ClonoSEQ® NGS testing and <5% blasts in the BM at screening

- Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

- Phase Ib (Cohort IA and Cohort IB) and Phase II (Cohort IIA and Cohort IIB) B-ALL with
isolated EM disease

- Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis

- History or presence of clinically relevant CNS pathology

- Presence of CNS-3 disease or CNS-2 disease with neurological changes

- Presence of active or uncontrolled fungal, bacterial, viral, or other infection
requiring systemic antimicrobials for management

- Active or latent Hepatitis B virus or active Hepatitis C virus

- Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test

- Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced
Grade 3 or higher neurotoxicity following blinatumomab.