Update on ARI-0001 for patients with CD19+ R/R malignancies

Marta Palhas — Fri, 26 Feb 2021 14:08:23 +0000

ARI-0001 is a novel second-generation autologous CD19 CAR-T cell that was evaluated in the Phase I CART19-BE-01 trial (NCT03144583). Clinical data showed ARI-0001 to be a safe and efficacious product, with persistence of CAR T-cells and response in patients with CD19+ relapsed/refractory (R/R) hematological malignancies. The CAR-T product is currently under review for approval by the Spanish Drug Agency (AEMPS) under the Hospital Exemption Rule. Manel Juan Otero, MD, PhD, Hospital Clínic de Barcelona, Barcelona, Spain, discusses the next steps for ARI-0001, including in combination with other approaches and finding new indications for the CAR-T product such as in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma. Additionally, Dr Juan Otero reveals that a new CAR T-cell targeting BCMA is being evaluated in multiple myeloma. This interview took place during the 3rd European CAR T-cell Meeting.

Regulatory considerations for CAR-T academic trials

Marta Palhas — Fri, 26 Feb 2021 14:08:23 +0000

Manel Juan Otero, MD, PhD, Hospital Clínic de Barcelona, Barcelona, Spain, explains how academic CAR-T clinical trials face more limitations regarding regulatory requirements than industry-initiated trials. For innovative technologies such as the CAR T-cell therapy, the current regulatory requirements can represent an enormous burden for academic institutions. To prevent the regulation from acting as an innovation blocker, regulatory and commercial aspects should be improved to promote the success of academic clinical trials in the field of cellular immunotherapies. This interview took place during the 3rd European CAR T-cell Meeting.

Manel Juan Otero – VJRegenMed

Update on ARI-0001 for patients with CD19+ R/R malignancies

Regulatory considerations for CAR-T academic trials