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Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results.
Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results. Nature medicine Mailankody, S., Matous, J. V., Chhabra, S., Liedtke, M., Sidana, S., Oluwole, O. O., Malik, S., Nath, R., Anwer, F., Cruz, J. C., Htut, M., Karski, E. E., Lovelace, W., Dillon, M., Butz, E., Ying, W., Balakumaran, A., Kumar, S. K. 2023Abstract
ALLO-715 is a first-in-class, allogeneic, anti-BCMA CAR T cell therapy engineered to abrogate graft-versus-host disease and minimize CAR T rejection. We evaluated escalating doses of ALLO-715 after lymphodepletion with an anti-CD52 antibody (ALLO-647)-containing regimen in 43 patients with relapsed/refractory multiple myeloma as part A of the ongoing first-in-human phase 1 UNIVERSAL trial. Primary objectives included determination of the safety and tolerability of ALLO-715 and the safety profile of the ALLO-647-containing lymphodepletion regimen. Key secondary endpoints were response rate and duration of response. Grade =3 adverse events were reported in 38 (88.0%) of patients. Cytokine release syndrome was observed in 24 patients (55.8%), with 1 grade =3 event (2.3%) and neurotoxicity in 6 patients (14%), with no grade =3 events. Infections occurred in 23 patients (53.5%), with 10 (23.3%) of grade =3. Overall, 24 patients (55.8%) had a response. Among patients treated with 320*106 CAR+ T cells and a fludarabine-, cyclophosphamide- and ALLO-647-based lymphodepletion regimen (n=24), 17 (70.8%) had a response including 11 (45.8%) with very good partial response or better and 6 (25%) with a complete response/stringent complete response. The median duration of response was 8.3months. These initial results support the feasibility and safety of allogeneic CAR T cell therapy for myeloma.
View details for DOI 10.1038/s41591-022-02182-7
View details for PubMedID 36690811