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 Refractory Acute Lymphoblastic Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 27, 2014

Primary Completion Date

April 26, 2018

Study Completion Date

April 26, 2018

Conditions
Patients With B Cell ALL, Relapsed or Refractory, With no Available Curative Treatment Options
Interventions
BIOLOGICAL

CART-19

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

BIOLOGICAL

CART-19

As of June 2014, dose was reduced to a single dose of 1-5x10\^7 CART-19 cells.

BIOLOGICAL

CART-19

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.

BIOLOGICAL

CART-19

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).

Trial Locations (1)

19104

Abramson Cancer Center of the University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

University of Pennsylvania

OTHER

NCT02030847 - 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 Refractory Acute Lymphoblastic Leukemia | Biotech Hunter | Biotech Hunter