PARAMETER

DATA

Manufacturer

Kite Pharma, Inc.

Transgene

CD19-directed gene

Indication

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Virus and Serotype

Murine stem cell virus (MSCV)-based vector

Cell Substrate

Anti-CD19 chimeric antigen receptor (CAR) T cells

Manufacturing platform

• PG13-CD19-H3 retroviral vector: The PG13-CD19-H3 vector is produced constitutively from a stably-transduced PG13 (ATCC CRL-10686) cell line. For the GMP-compliant production of the retroviral vector, cells from a single vial of WCB are expanded and the culture supernatant is harvested, filtered, and filled into cryostorage bags.
• KTE-X19: The manufacturing process of KTE-X19 starts with apheresis collection from a patient. The next steps in the manufacturing process include T-cell enrichment, T-cell activation, retroviral transduction and T-cell expansion.

Dose in vial/final container

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

Primary study

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

Supportive studies providing additional safety data

NCT02614066

1, 2

125

A study evaluating Brexucabtagene Autoleucel (KTE-X19) in adult subjects with relapsed/refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

United States, Canada, France, Germany, Netherlands

NCT02625480

1, 2

116

Study evaluating Brexucabtagene Autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory B-precursor Acute Lymphoblastic Leukemia or relapsed/refractory B-Cell Non-Hodgkin Lymphoma     

United States, Canada, France, Netherlands

NCT03624036

1

27

Safety and tolerability of Brexucabtagene Autoleucel (KTE-X19) in adults with relapsed/refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

United States, Italy