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Bijal Shah, MD, MS, associate member, Department of Malignant Hematology, Moffitt Cancer Center, discusses evaluating autologous CAT19-41BB-Z CAR T-cells (AUTO1) in relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL).
In the phase 1/2 multicenter FELIX trial (NCT04404660), AUTO1, a low-affinity CD19-directed CAR T-cell therapy, is being examined in patients with relapsed/refractory B-ALL, Shah explains. The FELIX trial is distinguished in the space based on the inclusion of a cohort with minimal residual disease–positive B-ALL, Shah adds.
The inclusion of the cohort is based on multiple retrospective observations supporting the idea that patients with low disease burden have optimal outcomes in terms of response duration and toxicity, Shah continues. Ideally, patients will have undetectable disease rather than low disease burden, Shah concludes.