Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

March 11, 2020

Study Completion Date

June 30, 2021

Conditions
Lymphoblastic Leukemia, Acute, Childhood
Interventions
DRUG

Tocilizumab

Patients with ≥ 40% blasts in the bone marrow at pre-infusion will be enrolled in the early tocilizumab cohort and will follow early CRS treatment algorithm.

DRUG

Tocilizumab

Patients with ˂ 40% blasts in the bone marrow at pre-infusion (\~ Day -5 to -1) will follow the standard CRS Rx algorithm

BIOLOGICAL

CART 19

CART-19 cells transduced with a lentiviral vector to express either anti-CD19ζ scFv TCRζ:41BB, administered by i.v. injection using an intra-patient dose escalation approach: 10% on day 0, 30% on day 1 with a total dose goal of \~1.5 x107 - 5 x109 (\~3x105 - 1x108/kg) T cells.

Trial Locations (1)

19104

Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
collaborator

Children's Hospital of Philadelphia

OTHER

lead

University of Pennsylvania

OTHER

NCT02906371 - Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome | Biotech Hunter | Biotech Hunter