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RecruitingPhase 2Phase 3NCT03937544

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

Sponsor

National University of Malaysia

Enrollment

10 participants

Start Date

Mar 19, 2019

Study Type

INTERVENTIONAL

Conditions

Relapsed B Acute Lymphoblastic LeukaemiaRefractory B Acute Lymphoblastic Leukaemia

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

Min Age: 13 YearsMax Age: 65 Years

Inclusion Criteria10

  • 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 Criteria10

  • 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.

Interventions

BIOLOGICALCD19 CAR-T CELLS

CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.

DRUGCyclophosphamide

Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).

DRUGFludarabine

Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).

Locations(1)

UKM Medical Centre

Bandar Tun Razak, Kuala Lumpur, Malaysia

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NCT03937544