CAR-T Meeting 2026 | Results of the Phase II CART19-BE-02 trial of var-cel (ARI-0001) in patients with R/R B-ALL
Valentín Ortiz-Maldonado, MD, Hospital Clinic Barcelona, Barcelona, Spain, discusses the Phase II multicenter CART19-BE-02 trial (NCT04778579), which investigated varnimcabtagene autoleucel (var-cel; ARI-0001) in adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), highlighting the trial’s stringent measurable residual disease (MRD)-based primary endpoint and fractionated adaptive interpatient dosing strategy. Dr Ortiz-Maldonado notes that the primary endpoint was met, with the majority of patients achieving MRD-negative complete remission (CR), and the durability of responses was encouraging. This interview took place at the EBMT-EHA 8th European CAR T-cell Meeting, held in Palma de Mallorca, Spain.
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Transcript
So, the CART19-BE-02 trial was a multicenter trial, was a phase two conducted across nine Spanish centers, that included patients with relapsed/refractory B-cell lymphoma. So, one of the most important aspects of the study is how we did define success. This was not just, you know, morphological remission, but our primary endpoint was complete response with undetected MRD at 10 to the minus five at day 28...
So, the CART19-BE-02 trial was a multicenter trial, was a phase two conducted across nine Spanish centers, that included patients with relapsed/refractory B-cell lymphoma. So, one of the most important aspects of the study is how we did define success. This was not just, you know, morphological remission, but our primary endpoint was complete response with undetected MRD at 10 to the minus five at day 28. So we deliberately chose a stringent MRD-based endpoint, basically to align with contemporary clinical decision-making and not just traditional morphological response, which is used in most of the other trials. And the other key distinctive feature was that we were using a fractionated adaptive interpatient dosing strategy, which instead of giving a full dose of CAR T-cells in one go, we administer escalating fractions over several days with safety checks before each infusion. So with this approach, we basically reflect something very practical, which is that patients are biologically heterogeneous. And, you know, disease burden differs, expansion kinetics differs. So we designed a strategy to allow us to basically listen to the biology of patients in real time. And by doing this, it’s basically a CAR T-cell approach that adapts to patients and not the other way around.
So, yeah, so finally, the primary endpoint was met. About more than 80% of patients were able to achieve an MRD-negative complete remission at day 28. So this was even higher within the first three months, which was up to 95% of patients in the patients that were able to receive the maximum var-cel dose. So very importantly, this also translated into the durability of response. Those patients that received any amount of var-cel doses had a median duration of response that was around a year, and among those patients that were able to receive the full or the maximum dose, we have a median duration of response of around 16 months.
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Disclosures
Travel grants or honoraria: BMS and Pfizer.
