Multiple Myeloma (MM) is a lethal disease and at present no available treatment method seems to prevent the disease from progressing or relapsing in the long term. NK cells have a relatively high cytotoxic capacity and an anti tumour effect, suggesting a potential as a treatment of MM.This is a phase I, first-in-human, therapeutic exploratory study, where no benefits for the patients can be guaranteed. However, the theoretical implication is that the infused cells may have a positive antitumour effect for the participating individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Autologous ex vivo expanded and activated NK cells
Karolinska University Hospital
Stockholm, Sweden
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Assessment of treatment-emergent adverse events/serious adverse events (TEAEs/SEAS)(including IARS). TEAEs are defined as AEs that develop, worsen (according to the Investigators opinion), or bedome serious during the treatment period.
Time frame: From first dose of study treatment up until six months from last infusion.
Changes on serum monoclonal immunoglobulin levels as a marker of efficacy
Changes in absolute and relative levels of laboratory parameters
Time frame: From date of screening through study completion, up until six months from last infusion
Changes on urine monoclonal immunoglobulin levels as a marker of efficacy
Changes in absolute and relative levels of laboratory parameters
Time frame: From date of screening through study completion, up until six months from last infusion
Changes on serum free light chain levels as a marker of efficacy
Changes in absolute and relative levels of laboratory parameters
Time frame: From date of screening through study completion, up until six months from last infusion
Effect of CellProtect on plasma cell fraction in bone marrow
Changes in bone marrow clonal plasma cells
Time frame: From date of screening up until one month from last infusion
Response assessment as defined by the International Myeloma Working Group uniform response criteria
Evaluation of response criteria, i.e. minimal response, partial response, very good partial response and complete response as assessed by International Myeloma Working Group uniform response criteria
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Time frame: From date of screening up until six months from last infusion