Health Trials

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

ConditionsRelapsed B Acute Lymphoblastic LeukaemiaRefractory B Acute Lymphoblastic Leukaemia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age13-65
SponsorNational University of Malaysia

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CD19 CAR-T CELLS
  • Cyclophosphamide
  • Fludarabine

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

UKM Medical CentreRecruiting56000, Bandar Tun Razak, Kuala LumpurMalaysiaMalaysia

Sponsors and collaborators

National University of Malaysia

Lead sponsor

Gaia Science

Collaborator

Source ClinicalTrials.gov