This study will find the maximum tolerated dose (MTD) of CYNK-001 which contain NK cells derived from human placental CD34+ cells and culture-expanded. CYNK-001 cells will be given post Autologous Stem Cell Transplant (ASCT). The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating Multiple Myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
Colorado Blood Cancer Institute
Denver, Colorado, United States
Washington University
St Louis, Missouri, United States
Roswell Park Comprehensive Cancer Institute
Buffalo, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
Dose-Limiting Toxicity (DLT)
Safety Assessment of Dose-Limiting Toxicity (DLT)
Time frame: Up to 28 days
Maximum Tolerated Dose (MTD) or Maximum Planned Dose (MPD)
Safety Assessment of MTD OR MPD
Time frame: Up to 28 days
Adverse Events (AE)
Safety Assessment of AE's
Time frame: Up to 12 months
Rate of Minimal Residual Disease (MRD) Negativity
Efficacy Assessment of MRD
Time frame: Day 90-100
Minimal Residual Disease (MRD) Response
Efficacy Assessment of MRD
Time frame: Day 90-100
Time to MRD Response
Efficacy Assessment of MRD
Time frame: up to 12 months
International Myeloma Working Group (IMWG) response
Efficacy Assessment of response
Time frame: up to 12 months
duration of clinical response
Efficacy Assessment of response
Time frame: up to 12 months
Progression-free survival
Efficacy Assessment of response
Time frame: up to 12 months
time to progression
Efficacy Assessment of response
Time frame: up to 12 months
overall survival
Efficacy Assessment of response
Time frame: up to 12 months
Quality of life questionnaire
Efficacy Assessment of response
Time frame: up to 12 months
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