A phase I, dose-escalation study showed an 82% complete remission (CR) rate after a single dose of the CD19 chimeric antigen receptor (CAR) T-cell therapy anbalcabtagene autoleucel (anbal-cel) in patients with relapsed/refractory large B-cell lymphoma (LBCL). The results of the study were presented at the 2022 European Hematology Association Congress.
In the study, 11 patients with relapsed/refractory diffuse LBCL were infused with anbal-cel. All patients had received two or more prior lines of therapy, and 36% (n=4) had received four or more prior lines of treatment.
Lymphodepletion with cyclophosphamide 500 mg/m2 and fludarabine 30 mg/m2 was performed for three days prior to anbal-cel infusion. The patients were then administered anbal-cel in a single intravenous dose of either 2×105 cells/kg, 7×105 cells/kg, or 2×106 cells/kg.
Of the four patients dosed with anbal-cel at 2×105 cells/kg, three experienced CR, and two maintained CR for more than a year at the time of reporting. All patients dosed with 2×106 cells/kg reported CR after a single dose. The overall CR rate was 82% (n=9).
“We are very excited about this promising clinical result, even though the patient number treated with anbal-cel is limited with a total of 11, and looking forward to the ongoing phase II clinical trial to confirm the efficacy and safety of anbal-cel,” Gunsoo Kim, Chief Executive Officer of Curocell, manufacturer of anbal-cel, said in a statement.
Source: Curocell Press Release, June 2022