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iwCLL 2025 | Safety and efficacy of var-cel (ARI-0001) in patients with R/R CLL and Richter’s transformation
Nil Albiol, MD, Hospital Clínic de Barcelona, Barcelona, Spain, shares the results of a retrospective study assessing the safety and efficacy of the academic CD19-directed CAR T-cell construct varnimcabtagene autoleucel (var-cel; ARI-0001) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) and Richter’s transformation (RT). The outcomes with this CAR T-cell therapy have been encouraging, and the dosing schedule used has resulted in a low incidence of treatment-related toxicities. This interview took place at the biennial International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2025 in Krakow, Poland.
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Transcript
So this is a retrospective study in which we collected the data from patients in our institution and other Spanish institutions as well. And we treated 13 patients with CLL and 16 with Richter’s. And the overall response rate was around 86%, a bit lower for the CLL patients, and at almost 1.3 years of follow-up, we have not reached the median PFS or the median OS, but the estimated one-year PFS is 80%, and the four-year PFS around 60%...
So this is a retrospective study in which we collected the data from patients in our institution and other Spanish institutions as well. And we treated 13 patients with CLL and 16 with Richter’s. And the overall response rate was around 86%, a bit lower for the CLL patients, and at almost 1.3 years of follow-up, we have not reached the median PFS or the median OS, but the estimated one-year PFS is 80%, and the four-year PFS around 60%.
So there are no safety signals so far with this cohort. We produced the CAR-T in a median of eight days with a median vein-to-vein time of 35 days, which is quite impressive. And in terms of safety, we already know that ARI-0001 is a really safe product because we do an intrapatient escalating dose, splitting the dose in three fractions, and we only administer the next dose if the previous one has not aroused any toxicity. So in comparison with other commercial CAR-Ts like liso-cel or brexu-cel, we have obtained a pretty low incidence of ICANS, just 6% and all of them were grade 2 or lower, and we saw around 90% of CRS, but all low grade. We have proof that most of these patients, especially those who achieve complete response, do not relapse. At long follow-up, we have not seen late relapses, so maybe we hypothesize that it can cure both diseases, both CLL and Richter’s, and it can be a feasible treatment for third line and onwards.
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