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

Summary

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.

Conditions3

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