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

Summary

SJCAR19 is a research study seeking to evaluate the use of chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of pediatric, adolescent and young adult patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL). CAR therapy combines two of the body's basic disease fighters: antibodies and T Cells. For this type of therapy, peripheral (circulating) immune cells are collected and then undergo a manufacturing process to engineer them to more effectively kill cancer cells. The SJCAR19 product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The main purpose of this study is to determine: 1. The largest dose of SJCAR19 that is safe to give, 2. How long SJCAR19 cells last in the body, 3. The side effects of SJCAR19, and 4. Whether or not treatment with SJCAR19 is effective in treating people with refractory or relapsed ALL.

Timeline

Start

2018-07-24

Primary completion

2023-07-01

Completion

2026-07-01

Publications

• Talleur AC, Qudeimat A, Metais JY, Langfitt D, Mamcarz E, Crawford JC, Huang S, Cheng C, Hurley C, Madden R, Sharma A, Suliman A, Srinivasan A, Velasquez MP, Obeng EA, Willis C, Akel S, Karol SE, Inaba H, Bragg A, Zheng W, Zhou SM, Schell S, Tuggle-Brown M, Cullins D, Patil SL, Li Y, Thomas PG, Zebley C, Youngblood B, Pui CH, Lockey T, Geiger TL, Meagher MM, Triplett BM, Gottschalk S. Preferential expansion of CD8+ CD19-CAR T cells postinfusion and the role of disease burden on outcome in pediatric B-ALL. Blood Adv. 2022 Nov 8;6(21):5737-5749. doi: 10.1182/bloodadvances.2021006293.

Drugs

Indications