CD19x22 CAR T Cells

Autologous peripheral blood mononuclear cells transduced with CD19x22 CAR T lentiviral vector.

To determine the safety and tolerability of infusing CD19x22 CAR T, generated using a bicistronic vector, in adolescents and adults with R/R B-NHL, and to determine the recommended Phase II dose (RP2D). Secondary objectives for all subjects include: 1) Feasibility of manufacturing and infusion, 2) Safety of infusion and 3) Efficacy: Descriptive characterization of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) at Day +90.

As well, progression-free survival (PFS), overall survival (OS), duration of remission (DOR) and overall response rate (ORR) will be determined at 1 year. Efficacy will be descriptively stratified based on prior receipt of CAR-T cell therapy.

This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.

Live record on ClinicalTrials.gov →

• Age: ≥ 16 years of age with no upper age limit. (NOTE: the first three subjects on this trial must be ≥ 18 years of age.)
• COHORT 1: Non-CNS B-NHL
• Histologically confirmed aggressive B-cell NHL including the following types defined by World Health Organization (WHO) 2008:
• Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr Virus (EBV)+ DLBCL of the elderly; OR
• Primary mediastinal (thymic) large B cell lymphoma; OR
• Transformation to DLBCL; OR

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.