Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

A Phase II/III Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed/ Refractory B-Acute Lymphoblastic Leukaemia

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Inclusion Criteria:

• Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics
• Age between ≥13 to ≤ 65 years
• No detectable leukaemia in the CSF (CNS-1)
• CNS leukaemia without clinically evident neurological symptoms (CNS-2; with <5 WBC per μL and cytology positive for blasts)
• Adequate organ function as defined by a creatinine clearance > 50 ml/min, serum total bilirubin < 5 times the normal value, left ventricular ejection fraction > 40%
• ECOG performance status ≤ 2
• Life expectancy > 3 months
• Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression
• Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods
• Male patients must use highly effective contraception methods

Exclusion Criteria:

• Patients with CNS-3 leukaemia.
• Active cancer (other than B-ALL).
• Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.
• Presence of active autoimmune disease or atopic allergy.
• HIV serology positivity.
• Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
• Uncontrolled sepsis
• Pregnant / nursing female.
• Ongoing prednisolone > 1mg/kg daily or equivalent.
• Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.