A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

This is an interventional treatment trial for Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia focused on measuring B cell acute lymphoblastic leukemia, Relapsed B cell acute lymphoblastic leukemia, Refractory B cell acute lymphoblastic leukemia, ALL, AUTO1, CD19-positive CAR T cell Read More

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.