CARTITUDE-1, A PHASE 1B/2 STUDY OF CILTACABTAGENE AUTOLEUCEL IN
RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)
Deepu Madduri1, Jesus G. Berdeja2, Saad Z. Usmani3, Andrzej Jakubowiak4, Mounzer Agha5, Adam D.
Cohen6, A Keith Stewart7, Parameswaran Hari8, Myo Htut9, Elizabeth O’Donnell10, Nikhil C. Munshi11,
David Avigan12, Abhinav Deol13, Alexander Lesokhin14, Indrajeet Singh15, Enrique Zudaire15, Tzu-Min
Yeh16, Alicia J. Allred15, Yunsi Olyslager17, Arnob Banerjee15, Jenna D. Goldberg16, Jordan M. Schecter18,
Carolyn C. Jackson16, William Deraedt17, Sen Hong Zhuang16, Jeffrey Infante16, Dong Geng19, Xiaoling
Wu19, Marlene J. Carrasco-Alfonso19, Muhammad Akram19, Farah Hossain19, Syed Rizvi19, Frank Fan20,
Sundar Jagannath1, Yi Lin21 and Thomas Martin22
(1)Mount Sinai Medical Center, New York, NY
(2)Sarah Cannon Research Institute, Nashville, TN
(3)Levine Cancer Institute-Atrium Health, Charlotte, NC
(4)University of Chicago Medical Center, Chicago, IL
(5)UPMC Hillman Cancer Center, Pittsburgh, PA
(6)Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA
(7)UHN and the Princess Margaret Cancer Centre, Toronto, ON, Canada
(8)Medical College of Wisconsin, Milwaukee, WI
(9)City of Hope Comprehensive Cancer Center, Duarte, CA
(10)Massachusetts General Hospital, Harvard Medical School, Boston, MA
(11)Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA
(12)Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
(13)Karmanos Cancer Institute, Wayne State University, Detroit, MI
(14)Memorial Sloan Kettering Cancer Center, New York, NY
(15)Janssen R&D, Spring House, PA
(16)Janssen R&D, Raritan, NJ
(17)Janssen R&D, Beerse, Belgium
(18)Janssen Research & Development, Raritan, NJ
(19)Legend Biotech USA Inc., Piscataway, NJ
(20)Nanjing Legend Biotechnology Co., Ltd., Nanjing, China
(21)Mayo Clinic, Rochester, MN
(22)Department of Medicine, University of California San Francisco, San Francisco, CA
Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor T (CAR-T) cell therapy with 2 B-cell
maturation antigen-targeting single-domain antibodies designed to confer avidity. We present
updated phase 1b data and initial phase 2 data from CARTITUDE-1 (NCT03548207).
Eligible patients had MM per IMWG criteria, measurable disease, received ≥3 prior regimens (or double
refractory to a proteasome inhibitor and immunomodulatory drug), and received an anti-CD38.
Bridging therapy was permitted after apheresis. After cyclophosphamide (300 mg/m2) / fludarabine
(30 mg/m2) lymphodepletion over 3 days, a single cilta-cel targeted dose of 0.75×106 (0.5–1.0×106)
CAR+ viable T cells/kg was infused. Primary objectives were to characterize the safety and establish
the recommended phase 2 dose of cilta-cel (phase 1b) and to evaluate efficacy (phase 2). Response
was assessed per IMWG criteria and minimal residual disease (MRD) by next-generation sequencing.
Adverse events (AEs) were graded using CTCAE v5.0. Cytokine release syndrome (CRS) was graded
using Lee et al (Blood 2014) and neurotoxicity using CTCAE in phase 1b; both were graded using ASTCT
criteria in phase 2. In this combined analysis, Lee et al and CTCAE were mapped to ASTCT criteria for
CRS and immune effector cell-associated neurotoxicity syndrome, respectively.