The purpose of this study is to determine the safety and tolerability of an experimental form of therapy called UCARTCS1A (sometimes referred to as the “study drug”). UCARTCS1A cells (allogeneic engineered T-cells expressing anti-CS1 chimeric antigen receptor) are special types of cells called T-cells that have been collected from a donor and then are genetically modified (changed). T-cells are related to your immune system, which helps to fight infection. The study doctor can describe how the study drug is designed to work.
UCARTCS1A is an investigational product. This means that UCARTCS1A is still being studied. It also means that the U.S. Food and Drug Administration (FDA) and other regulatory authorities do not allow it to be sold for treating patients. The regulatory authorities only allow UCARTCS1A to be used in research. This study is being done to look at:
There are 2 parts to the study: (1) dose escalation and (2) dose expansion.
The goal of the first part (Part 1) of this study is to test the safety and tolerability of up to 3 different doses of UCARTCS1A and to find the highest well-tolerated dose of UCARTCS1A that can be given to patients with multiple myeloma, including those who have relapsed (disease has come back) or whose disease is refractory (has not responded to treatment).
The goal of the second part of the study (Part 2), dose expansion, is to learn about the safety and efficacy of the dose of UCARTCS1A that was determined during part 1 of the study.
Detailed eligibility will be reviewed when you contact the study team.