AbelZeta Presents Data from Two Clinical Studies Relating to its Immuno-Oncology Drug Development at the 65th ASH Annual Meeting

Between November 5, 2019, and January 11, 2022, 48 patients received C-CAR039 at the dose ranges of 1.0 x 106 to 5.0×106 CAR-T cells/kg. Of the 48 patients, 44 (91.7%) patients had large B-cell lymphoma (LBCL) (DLBCL, n=37; PMBCL, n=3; tFL, n=4), 3 patients had FL and 1 patient had MCL. The median age was 55 (range, 25-71) years, and 11 (22.9%) patients were ≥ 65 years. Thirty-six (75%) patients were in Ann Arbor Stage III/IV with 3 median prior lines of therapy, 32 (66.7%) patients were refractory to their last treatment, and 22 (45.8%) patients never achieved CR to their prior therapies. As of September 25, 2023, 45 patients (93.8%) experienced CRS, only 1 (2.1%) were grade 3. Three patients had grade 1 or 2 ICANS at a dose of 5.0×106 CAR-T cells/kg. Grade 3 or higher cytopenia not resolved by Day 30 following C-CAR039 infusion included neutropenia (54.2%), thrombocytopenia (20.8%), and anemia (20.8%). At cutoff date, 66.7% patients had infections with 25% grade 3 or higher. Second primary malignancy after C-CAR039 infusion was observed in 3 patients and none were related to C-CAR039. Fifteen deaths occurred, 11 due to disease progression. Of the 48 patients, 47 patients were evaluable for efficacy. The median follow-up time was 30.0 months. The ORR and CR rate among evaluable patients were 91.5% and 85.1% respectively. Of the 43 LBCL patients, the ORR was 90.7%, with 86.0% CR. Median duration of response (DOR) was not reached. 23/47 (48.9%) patients remain in CR, 10 of them for more than 36 months. Median PFS has not been reached. KM estimates of 24-m PFS rate were 62.6% (all patients) and 64.1% (LBCL). Median OS has not been reached. KM estimates of 24-m OS rate were 76.5% (all patients) and 79.0% (LBCL). The complete text of the abstract can be found https://ash.confex.com/ash/2023/webprogram/Paper182817.html

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