What is the purpose of this study?

CARTITUDE-1 consists of a phase Ib/II portion. The primary objective of the phase Ib was to characterize its safety and confirm the recommended phase II dose, as inferred by the LEGEND-2 study, but in a slightly different population. The primary objective of the phase II portion is to evaluate its efficacy. CARTITUDE-1 used JNJ4528, which now has a name, ciltacabtagene autoleucel or cilta-cel. It’s a structurally distinct second-generation chimeric antigen receptor (CAR) T-cell therapy with two BCMA-binding domains.

In this video:

Dr. Deepu Madduri presented the updated phase Ib data alongside with the initial phase II data from the CARTITUDE-1 trial.

Results:

Some of the takeaways from cilta-cel is that it had a manageable safety profile, with 95% of the patients having grade 1 and 2 cytokine release syndrome (CRS). CRS is a very known complication of CAR T-cell therapy. And most of the patients had grade 1 and 2 CRS with very little grade 3 or higher CRS. Another complication that’s known with CAR T-cell therapy is neurotoxicity. We saw about 21% having all-grade neurotoxicity, with about 10% having grade 3 or higher.

Conclusion:

A single low-dose infusion of ciltacabtagene autoleucel (cilta-cel), an autologous chimeric antigen receptor (CAR) T-cell therapy, was safe and associated with early, deep, and durable responses in patients with heavily pretreated multiple myeloma (MM), according to preliminary data from the phase Ib/II CARTITUDE-1 trial.

ASH 2020: Abstract 177

Deepu Madduri, MD 

Deepu Madduri, MD is Assistant Professor of Medicine (Hematology and Medical Oncology) and Assistant Director, Cellular Therapy Service, with the Center of Excellence for Multiple Myeloma at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai. Dr. Madduri specializes in plasma cell disorders including multiple myeloma, amyloid light-chain amyloidosis, POEMS syndrome, plasmacytoma, and monoclonal gammopathies of uncertain significance. She performs a variety of procedures including bone marrow biopsies and stem cell transplant. She serves as the lead physician liaison between the Center of Excellence for Multiple Myeloma and the Bone Marrow and Stem Cell Transplantation Program at The Mount Sinai Hospital. Visit Dr. Deepu Madduri’s full biography