Autologous HER2-specific CAR T cells after lymphodepletion for advanced sarcoma: a phase 1 trial.

ABSTRACT: In this prospective, interventional phase 1 study for individuals with advanced sarcoma, we infused autologous HER2-specific chimeric antigen receptor T cells (HER2 CAR T cells) after lymphodepletion with fludarabine (Flu) ± cyclophosphamide (Cy): 1 × 10⁸ T cells per m² after Flu (cohort A) or Flu/Cy (cohort B) and 1 × 10⁸ CAR⁺ T cells per m² after Flu/Cy (cohort C). The primary outcome was assessment of safety of one dose of HER2 CAR T cells after lymphodepletion. Determination of antitumor responses was the secondary outcome. Thirteen individuals were treated in 14 enrollments, and seven received multiple infusions. HER2 CAR T cells expanded after 19 of 21 infusions. Nine of 12 individuals in cohorts A and B developed grade 1-2 cytok

SUBMITTER: Hegde M 

PROVIDER: S-EPMC11588040 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature