NCT03573700View on ClinicalTrials.gov

Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 24, 2018

Primary Completion Date

July 1, 2023

Study Completion Date

July 1, 2025

Conditions
Acute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia, Refractory
Interventions
DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Mesna

Given IV

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

BIOLOGICAL

CD19- specific CAR engineered autologous T-cells (SJCAR19 product)

Given IV

Trial Locations (1)

38105

St. Jude Children's Research Hospital, Memphis

All Listed Sponsors
lead

St. Jude Children's Research Hospital

OTHER

NCT03573700 - Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter