Jesus G. Berdeja, MD

Jesus G. Berdeja, MD, the director of Multiple Myeloma Research at Sarah Cannon Research Institute, discusses the dosing of the investigational CAR T-cell product JNJ-4528 in patients with ​relapsed/refractory multiple myeloma.

The median administered dose of JNJ-4528 in the ​phase 1b/2 CARTITUDE-1 trial was 0.72 x 106 CAR + viable T cells/kg,which is lower than other available CAR T-cell products, says Berdeja.

With this dosing strategy, a 70 kg patient would receive about 50 million CAR T cells, explains Berdeja. Although additional information is needed, making fewer CAR T cells may lead to less manufacturing failures.

Moreover, data from the ​CARTITUDE-1 trial showed that the ​median time to onset of cytokine release syndrome (CRS) was 7 days after receiving JNJ-4528. Comparatively, CRS can be observed immediately after infusion with other ​CAR T-cell products, Berdeja concludes.

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Jesus G. Berdeja, MD, discusses the dosing of the investigational CAR T-cell product JNJ-4528 in patients with ​relapsed/refractory multiple myeloma.

Dr.  Berdeja on Dosing JNJ-4528 in Relapsed/Refractory Multiple Myeloma

Jesus G. Berdeja, MD, the director of Multiple Myeloma Research at Sarah Cannon Research Institute, discusses updated safety results from the ongoing phase 1b/2 CARTITUDE-1 trial (NCT03548207) with the CAR T-cell therapy JNJ-4528 in multiple myeloma.

In the study, neurotoxicity was rare; only 1 patient reported an event that was grade 3 or higher in severity, Berdeja says. Significant cytopenias were also observed with JNJ-4528, including neutropenia and thrombocytopenia, although most events resolved within 60 days, says Berdeja. All-grade upper respiratory tract infections were reported in 31% of the patients, however, none of these infections were unexpected, adds Berdeja.

Additionally, results showed a 100% overall response rate with the product, which included a stringent complete response rate of 86% and very good partial response rate of 97% at a median follow-up of 11.5 months, explains Berdeja.

Finally, 16 patients with a CR achieved minimal residual disease (MRD)–negative disease status. Of those patients, 81% were MRD negative at 10-5 or better and 69% were MRD negative at 10-6. The estimated progression-free survival rate at 9 months was 86%, concludes Berdeja.

Jesus G. Berdeja, MD, discusses updated safety results from the ongoing phase 1b/2 CARTITUDE-1 trial (NCT03548207) with the CAR T-cell therapy JNJ-4528 in multiple myeloma.

Jesus G. Berdeja, MD

Articles

Dr. Berdeja on Dosing JNJ-4528 in Relapsed/Refractory Multiple Myeloma

Dr. Berdeja on Updated CARTITUDE-1 Results With JNJ-4258 in Multiple Myeloma