ARI-0001 – VJRegenMed

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.

ARI-0001 CART19 cells in R/R B-ALL with isolated extramedullary disease

admin_vjr_user — Fri, 26 Feb 2021 14:08:22 +0000

Valentín Ortiz-Maldonado, MD, Hospital Clínic de Barcelona, Barcelona, Spain, discusses the safety and efficacy outcomes of ARI-0001 CART19 cell therapy in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) with isolated extramedullary disease. Results show a good safety profile, the incidence of cytokine-release syndrome (CRS) was 40%, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. Additionally, ARI-0001 therapy was able to achieve long-term remissions in this population of patients. This interview took place during the 3rd European CAR T-cell Meeting.

ARI-0001 in CD19+ malignancies: next steps

Marta Palhas — Fri, 26 Feb 2021 14:08:21 +0000

Valentín Ortiz-Maldonado, MD, Hospital Clínic de Barcelona, Barcelona, Spain, shares that the CD19 CAR-T cell product, ARI-0001, is currently under review for approval by the Spanish Drug Agency (AEMPS) under the Hospital Exemption Rule. In addition to this, a Phase II multicenter clinical trial is starting in adult acute lymphoblastic leukemia (ALL) with ARI-0001 cell therapy but with a higher dose to improve the duration of response. This interview took place during the 3rd European CAR T-cell Meeting.

CART19-BE-01: ARI-0001 in CD19+ malignancies

admin_vjr_user — Tue, 03 Nov 2020 17:40:00 +0000

Valentín Ortiz-Maldonado, MD, of the Hospital Clinic, Barcelona, Spain, discusses the initial results of the CART19-BE-01 (NCT03144583), a Phase I multicenter study evaluating ARI-0001, a CD19 targeting chimeric antigen receptor T-cell, in patients with CD19+ relapsed/refractory hematological malignancies. The primary and secondary endpoints of safety and efficacy were met, with an overall survival of 68.6% at one year. This interview was recorded via an online conference call with The Video Journal of Regenerative Medicine (VJRegenMed).

Sinusoidal obstruction syndrome in patients with R/R B-cell ALL

admin_vjr_user — Thu, 08 Oct 2020 14:08:11 +0000

Valentín Ortiz-Maldonado, MD, Hospital Clinic, Barcelona, Spain, discusses sinusoidal obstruction syndrome in patients with relapsed-refractory (R/R) B-cell acute lymphoblastic leukemia (ALL) treated with ARI-0001 CAR T-cells. This interview was recorded via an online conference call with The Video Journal of Regenerative Medicine (VJRegenMed).