This is a phase 1b, open-label, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma.
This is a phase 1b, open-label, multicenter, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma. The study will determine the MTD and RP2D, assessing safety and preliminary efficacy using a conventional 3+3 study design with two design stages, an ascending dose stage followed by an expansion study. Patients will be enrolled sequentially within each cohort and between cohorts during the dose escalation portion of the study with the staggered intervals of at least 28 days. Only one patient will be allowed to receive study treatment at any time through the end of the staggering period before the next subject may begin study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Anti-CD38 A2 KOKI DAR T cells
UC Irvine
Orange, California, United States
NOT_YET_RECRUITINGUC Davis
Sacramento, California, United States
NOT_YET_RECRUITINGUniversity of Oklahoma
Oklahoma City, Oklahoma, United States
RECRUITINGSafety of STI-1492
Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities
Time frame: Baseline through study completion at up to approximately 54 months
Overall response and duration
Response and duration according to the International Myeloma Working Group (IMWG) response criteria
Time frame: Baseline through study completion at up to approximately 54 months
Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)
Assessment of improvement in CRAB criteria
Time frame: Baseline through study completion at up to approximately 54 months
Assessment of serum immunoglobulin levels
Assessment of serum immunoglobulin levels
Time frame: Baseline through study completion at up to approximately 54 months
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