At a glance
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Phase II Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant or RefractoryAcute Lymphoblastic Leukemia
In Brief
A Phase 2 clinical trial evaluating CART-19 for Patients With B Cell ALL, Relapsed or Refractory, With no Available Curative Treatment Options. Completed, enrolled 42 participants across 1 site.
Detailed Summary
This is a single center, single arm, open-label phase II study to determine the efficacy and safety of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR/4-1BB) co-stimulatory domains (referred to as CART-19 cells) in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Inclusion criteria are designed to include adult patients aged greater than 18 with B cell ALL, relapsed or refractory, with no available curative treatment options (such as autologous or allogeneic stem cell transplantation) who have limited prognosis (greater than 12 weeks survival expectancy) with currently available therapies. The study product is CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 108 transduced CAR T cells.
Study Details
Timeline
Interventions
CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10\^8 transduced CAR T cells
As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.
In the protocol amendment in November 2014, the dose remained 1-5 x 10\^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
In the protocol amendment in May 2015, the dose was changed to 1-5 x 10\^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10\^7), 30% on Day 2 (3x10\^7-1.5x10\^8), 60% on Day 3 (6x10\^7-3x10\^8).