This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Center for Cancer and Blood Disorders (AON)
Bethesda, Maryland, United States
Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM)
Results will be descriptive. Safety and tolerability endpoints are adverse events and serious adverse events as proportion of all participants at a given dose level and in the overall study population.
Time frame: Day -60 to Month 12
To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival
Efficacy will be assessed by descriptive statistics of treatment response per IMWG criteria. Efficacy endpoints will be reported as proportion of participants achieving Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR) and stringent Complete Response (sCR) as the best response at a given dose level and in the overall study population.
Time frame: Day 1 to Month 12
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