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Tumor burden-guided dosing of obe-cel in patients with R/R B-cell ALL: Results from the FELIX trial
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The phase Ib/II FELIX trial (NCT04404660) evaluated the safety and efficacy of obe-cel, a novel autologous CD19 CAR T-cell therapy, in 127 adult patients with R/R B-ALL.1 Patients received obe-cel based on a TB-guided dosing schedule. Results from this trial were presented at the SOHO 2024 Annual Meeting by Elias Jabbour.1
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| Key learnings |
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High CAR T-cell expansion was observed, with median peak expansion achieved after Dose 2 in both low- and high-TB-guided groups, demonstrating the beneficial effects of these doses independent of TB. |
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The ORR was 78.0%, 73.3%, and 84.6% in all patients, high-TB patients (n = 75), and low-TB patients (n = 52), respectively. CR rates were 57.5%, 56.0%, and 59.6%, respectively. |
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TB-guided dosing of obe-cel was associated with a manageable safety profile, including in high-TB patients. Obe-cel-related Grade ≥3 AEs were reported in 60.6% of all patients, 57.3% of high-TB patients, and 65.4% of low-TB patients. Grade ≥3 CRS occurred in 2.4%, 2.7%, and 1.9%, while ICANS occurred in 7.1%, 9.3%, and 3.8% of all patients, high-TB patients, and low-TB patients, respectively. |
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The TB-guided administration of obe-cel resulted in promising efficacy and low incidences of Grade ≥3 immunotoxicity, supporting its use in patients with R/R B-ALL. |
Abbreviations: AE, adverse event; B-ALL, B-cell acute lymphoblastic leukemia; CAR, chimeric antigen receptor; CR, complete remission; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity; obe-cel, obecabtagene autoleucel; ORR, overall response rate; R/R, relapsed/refractory; SOHO, Society of Hematologic Oncology; TB, tumor burden.
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