The academic point-of-care anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel (ARI-0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma

Br J Haematol. 2024 Feb;204(2):525-533. doi: 10.1111/bjh.19170. Epub 2023 Oct 31.

Abstract

Varnimcabtagene autoleucel (var-cel) is an academic anti-CD19 chimeric antigen receptor (CAR) product used for the treatment of non-Hodgkin lymphoma (NHL) in the CART19-BE-01 trial. Here we report updated outcomes of patients with NHL treated with var-cel. B-cell recovery was compared with patients with acute lymphoblastic leukaemia (ALL). Forty-five patients with NHL were treated. Cytokine release syndrome (any grade) occurred in 84% of patients (4% grade ≥3) and neurotoxicity in 7% (2% grade ≥3). The objective response rate was 73% at Day +100, and the 3-year duration of response was 56%. The 3-year progression-free and overall survival were 40% and 52% respectively. High lactate dehydrogenase was the only covariate with an impact on progression-free survival. The 3-year incidence of B-cell recovery was lower in patients with NHL compared to ALL (25% vs. 60%). In conclusion, in patients with NHL, the toxicity of var-cel was manageable, while B-cell recovery was significantly prolonged compared to ALL. This trial was registered as NCT03144583.

Keywords: CAR; CD19; NHL; var-cel.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies
  • Antigens, CD19
  • Humans
  • Immunotherapy, Adoptive / adverse effects
  • Lymphoma, B-Cell* / therapy
  • Lymphoma, Non-Hodgkin* / therapy
  • Point-of-Care Systems
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma* / therapy
  • Receptors, Chimeric Antigen*
  • T-Lymphocytes

Substances

  • Receptors, Chimeric Antigen
  • Antibodies
  • Antigens, CD19

Associated data

  • ClinicalTrials.gov/NCT03144583