The FDA has granted a fast track designation to PBCAR0191, a CD19-directed allogeneic chimeric antigen receptor T-cell therapy, for the treatment of patients with advanced B-cell precursor acute lymphoblastic leukemia.
An investigator-initiated trial of a humanized CD19-directed chimeric antigen receptor T-cell therapy has been completed, demonstrating the therapy may be a safe and effective treatment for patients with hematologic malignancies.
"These data are significant, as they demonstrate that CAR T-cell therapy may be a safe and effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen."
Tisagenlecleucel, a chimeric antigen receptor T-cell therapy, showed evidence of clinical benefit for patients with relapsed or refractory follicular lymphoma, in terms of complete response rate, meeting the primary end point of the phase 2 ELARA clinical trial.
Chimeric antigen receptor T-cell therapy when administered to patients with non-follicular low-grade lymphoma may experience different efficacy outcomes than patients with aggressive B-cell lymphomas, according to a single-institution retrospective data.