Overview
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
Eligibility
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.