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

Korábbi kezelés

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

Más betegség

• Phase 1b (Cohort IA and Cohort IB) and Phase 2 (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease
• 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

Egyéb

• Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis
• History or presence of clinically relevant CNS pathology

• 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 1b: Primary Cohort IA: Presence of ≥5% blasts in BM at screening
• Phase 1b: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and <5% blasts in the BM at screening
• Phase 2: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening
• Phase 2: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central NGS testing and <5% blasts in the BM at screening
• Adequate renal, hepatic, pulmonary, and cardiac function