Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

Summary

Objectives

This is a Phase II open-label study of anitocabtagene-autoleucel * in patients with
relapsed or refractory multiple myeloma (MM). The study will have the following
sequential phases: screening, enrollment, pre-treatment with lymphodepleting
chemotherapy, treatment with anitocabtagene-autoleucel , and follow-up. If necessary,
bridging therapy is allowed to control growth of MM disease while
anitocabtagene-autoleucel is being manufactured.

Following a single infusion of anitocabtagene-autoleucel both safety and efficacy data
will be assessed. Efficacy will be assessed monthly for the first 6 months, then
quarterly up to 2 years, or upon patient relapse. The primary analysis will be conducted
approximately 13 months after the final patient is dosed. This will allow approximately
12 months follow up from the time of the last observed response on study.

Long-term safety data will be collected under a separate long-term follow up study for up
to 15 years per health authority guidelines.

*Anitocabtagene-autoleucel drug product consists of autologous T cells that have been
genetically modified ex vivo to express a D-domain Chimeric Antigen Receptor (CAR),
followed by a cluster of differentiation 8 (CD8) hinge and transmembrane region that is
fused to the intracellular signaling domains for 4-1BB and CD3?, that specifically
recognizes B-cell maturation antigen (BCMA). The active substance of
anitocabtagene-autoleucel is CAR+ CD3+ T cells that have undergone ex vivo T-cell
activation, gene transfer by replication-deficient lentiviral vector, and expansion.