PARAMETER

DATA

Manufacturer

Kite Pharma, Incorporated

Transgene

Indication

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and To DLBCL arising from follicular lymphoma.

Virus and Serotype

Retroviral vector PG13-CD19-H3

Cell Substrate

Autologous stably-transduced PG13 (ATCC CRL-10686™) T cell

Manufacturing platform

Retroviral vector PG13-CD19-H3: The PG13-CD19-H3 vector is produced constitutively from a stably-transduced PG13 (ATCC CRL-10686™) cell line. For production of retroviral vector under GMP, cells from a single vial of WCB are expanded and the culture supernatant is harvested, filtered, and filled into cryostorage bags.

Axicabtagene ciloleucel: Autologous T cells genetically modified ex vivo by transduction with a retroviral vector to express an anti-CD19 CD28/CD3ζ CAR to target CD19 on the cell surface of malignant B cells.

Dose in vial/final container

Suspension of 2 × 106 CAR-positive viable T cells per kg of body weight, with a maximum of 2 × 108 CAR-positive viable T cells in approximately 68 mL

Dose/patient

2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells

NCT

TRIAL PHASE

SUBJECTS ENROLLED

STUDY TITLE

COUNTRIES

NCT02348216

1, 2

307

Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

United States, Canada, France, Germany, Israel, Netherlands

NCT02601313

2

105

Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma

United States, France, Germany, Netherlands