A phase I/II-trial with JNJ-4528 CAR-T cell therapy shows promising results for the use of JNJ-4528 in patients with refractory/relapsing (R/R) multiple myeloma (MM). Nine months after receiving a single infusion of JNJ-4528, the objective response rate (ORR) was 100%.
JNJ-4528 is a chimeric antigen receptor (CAR-T) cell therapy that encompasses 2 antigens that target the B-cell maturation antigen (BCMA). In the CARTITUDE-1-trial in which this therapy was researched, MM-patients received a single infusion of JNJ-4528 (median 0.73*106 CAR-T cells / kg ). The participants had received median 5 treatment lines (between 3-18) before entering the study.
After a follow-up of 9 months, 29 patients from the phase Ib-cohort were analysed. In these patients, an objective response rate (ORR) of 100% was found. Moreover, 22 patients (76%) showed a stringent complete response (sCR), 6 (21%) a very good partial response and 1 patients (3%) a partial response. The median time until CR was 2 months (1-9 months). From the analysed participants, 26 of 29 (90%) showed progression-free survival (PFS) with 93% PFS 6 months after treatment.
One patient passed away due to the cytokine release syndrome and 1 patients due to acute myeloid leukaemia (unrelated to treatment). Additionally, 100% of patients suffered from neutropenia (stage 3/4), 69% from thrombocytopenia (stage 3/4) and 59% from leukopenia (grade 3/4). Moreover, 27 patients (93%) developed cytokine release syndrome (CRS, 25 stage 1 or 2, 1 stage 3 and 1 stage 5). Median time until developing CRS was 7 days (2-12 days). Four of the patients developed treatment-related neurotoxicity.
The second phase of the study will continue for at least 2 years.