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MG4101

Phase 2

Hepatocellular Carcinoma | Monoclonal antibody | Oncology |Artiva Biotherapeutics, Inc.|Last Updated: Sep 26, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

MG4101 · 1 trial · 1 indication

Phase 2 1
NCT02854839A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular CarcinomaHepatocellular Carcinoma
COMPLETED78 Analytics
PHASE2COMPLETED
A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma
Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time To progression
every 12 weeks, up to the time of death or 18 months

Secondary Endpoints

Progression-free survival
every 12 weeks, up to the time of death or tumor progression, up to 18 months
Overall survival
every 12 weeks, up to the time of death, up to 18 months
change of Tumor Markers(AFP, Alpha-Fetoprotein)
every 12 weeks, up to the time of death or tumor progression, up to 18 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
The Control GroupNO_INTERVENTIONPatients will be randomized 1:1 to the control group and the treatment group. Patients who had allocated control group will not receive adjuvant treatment.
The Treatment Group (MG4101)EXPERIMENTALPatients will be randomized 1:1 to the control group and the treatment group. The treatment group will receive 6 times of MG4101(allogeneic natural killer cells) on week 0, 1, 2, 5, 6, 7.

Interventions

NameTypeDescription
MG4101BIOLOGICALMG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion criteria 1. Patients who are between 20 to 80 years of age 2. Life expectancy \> 12 weeks 3. Patients have complete remission according to the mRECIST by Dynamic contrast-enhanced 3- or 4-phase CT or tissue biopsy * Patients were diagnosed Hepatocellular Carcinoma BCLC stage B be-fore...

Countries:South Korea
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Frequently asked questions about MG4101

What is MG4101 used for in Hepatocellular Carcinoma?

MG4101 is an investigational allogeneic natural killer cell therapy being studied for the treatment of intermediate-stage hepatocellular carcinoma, a type of liver cancer. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does MG4101 target?

MG4101 is a monoclonal antibody-based therapy that utilizes allogeneic natural killer cells. Its mechanism involves the use of donor-derived natural killer cells to target and attack cancer cells, though the specific molecular target is not disclosed in the available clinical trial information.

Who makes MG4101?

MG4101 is being developed by Artiva Biotherapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ARTV on the stock market.

What phase is MG4101 in?

MG4101 is currently in Phase 2 clinical development. It has completed one Phase 2 clinical trial, and the drug remains investigational, meaning it has not received approval from regulatory agencies such as the FDA.

What clinical trials is MG4101 in?

MG4101 has been studied in a completed Phase 2 clinical trial with the identifier NCT02854839. This trial, titled 'A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma,' enrolled 78 participants in South Korea and included adults aged 18 years and older.

Is MG4101 the same as other natural killer cell therapies?

MG4101 is a specific allogeneic natural killer cell therapy developed by Artiva Biotherapeutics. It is not known to be the same as other natural killer cell therapies, as no alternative names have been reported for this investigational drug.