The propose of this study is evaluate the safety and efficacy of MG4101 (allogeneic Natural killer cells) in patients with hepatocellular carcinoma (HCC) after transarterial chemoembolization (TACE).
This is randomized, multi-center, open-labeled, Phase 2a study in patients with HCC after transarterial chemoembolization (TACE). A total of 78 patients will be randomized(1:1) into one of the two group, to receive adjuvant therapy using MG4101 (allogeneic Natural killer cells, Treatment group) or no adjuvant therapy (Control group). Patients who were assigned Treatment group will receive 2 cycles of MG4101 (each cycle is 3 treatments at a frequency of once per week, between each cycle has 3 weeks of withdrawal period). After treatment period, patients will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date. The Control group's patients will will undergo follow up for progression and survival every 12 weeks (± 7 days) and follow up 1 year after the last patient's enrollment date.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
MG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.
Seoul National University Hospital
Seoul, South Korea
Seoul Asan Medical center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea Univ. Guro Hospital
Seoul, South Korea
Time To progression
Time frame: every 12 weeks, up to the time of death or 18 months
Progression-free survival
Time frame: every 12 weeks, up to the time of death or tumor progression, up to 18 months
Overall survival
Time frame: every 12 weeks, up to the time of death, up to 18 months
change of Tumor Markers(AFP, Alpha-Fetoprotein)
Time frame: every 12 weeks, up to the time of death or tumor progression, up to 18 months
Safety of MG4101 as evaluated by Incidence of adverse events (AEs), serious adverse events (SAEs)
Time frame: up tp 9 weeks
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Severance hospital
Seoul, South Korea
Ajou Univ. Hospital
Suwon, South Korea