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Advanced Hepatocellular CarcinomaPhase 1NCT05783570

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307

A Phase 1 study testing EU307 CAR-T Cell in people with Advanced Hepatocellular Carcinoma, run by Eutilex at 4 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
EU307 CAR-T Cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
4 sitesSouth Korea
Study dates
24 Aug 2023to Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible, subjects must meet all of the following criteria:
  • Male or female adults ≥19 years old at the time of written informed consent
  • Patients with histologically or cytologically diagnosed unresectable HCC refractory to first- or second-line standard therapy* with no other standard therapy available
  • Including, but not limited to atezolizumab plus bevacizumab combination therapy and tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib).
  • Confirmed GPC3 positivity by IHC based on a liver tissue sample
  • At least 1 measurable lesion based on mRECIST v1.1
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  • Child-Pugh score Class A or Class B(7)
  • Life expectancy ≥3 months based on the judgment of the investigator
  • ECOG PS 0 or 1
  • Patients who have adequate bone marrow, liver, and kidney functions at the time of screening:
  • WBC ≥ 2,000 /μL ANC ≥ 1,000 /μL Platelet ≥ 80,000 /μL Hemoglobin ≥ 9.0 g/dL Albumin ≥ 2.8 g/dL AST and ALT ≤ 5ⅹULN Total bilirubin ≤ 2 x ULN Serum creatinine ≤1.5 x ULN Creatinine clearance (CrCl) ≥ 30 mL/min PT(INR) ≤1.5 x ULN
  • Negative serum pregnancy test in women of childbearing potential
  • Women of childbearing potential or men who do not plan a pregnancy during the study period and who agree to use clinically adequate methods of contraception as follows:
  • Hormone contraceptives (subcutaneous implants, injections, oral contraceptives, etc.), intrauterine device (IUD) (or intra uterine system [IUS]), subject's or partner's surgical sterilization (vasectomy, tubal ligation, etc.), double barrier methods (combined use of barrier methods such as combined use of cervical cap or diaphragm plus male condom)
  • Written informed consent to voluntary study participation

Who cannot join

  • Subjects who meet any of the following criteria cannot participate in the study:
  • Current disease and medical history
  • History or current evidence of hepatic encephalopathy
  • Patients with radiographic findings of brain metastases or spinal cord compression
  • Histologically confirmed HCC in ≥50% of the liver
  • Severe ascites requiring treatment such as paracentesis
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  • History or current evidence of the following infections:
  • Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
  • Active hepatitis B (However, if HBsAg is positive, and if it is low or undetectable HBV DNA (HBV DNA level <2,000 IU/mL) based on the site-specific criteria at screening and a prophylactic antiviral agent can be administered for 6 months after the administration of the investigational product, enrollment is possible at the discretion of the investigator.)
  • Active hepatitis C (However, patients who have undergone antiviral therapy and whose HCV viral load is negative based on the site-specific criteria will be allowed to be enrolled.)
  • Uncontrolled severe chronic infection or active infection
  • Prior or planned organ transplantation during the study period
  • Diagnosis of any malignant tumor other than the study indication within 5 years prior to screening (Patients who were treated and assessed as complete response [CR] without recurrence within 3 years or patients diagnosed with nonmelanoma skin cancer, in-situ disease, thyroid cancer, or borderline tumor will be allowed to be enrolled.)
  • Clinically significant, severe cardiac disease based on the judgment of the investigator (e.g., uncontrolled hypertension, congestive heart failure [NYHA Grade ≥2], ventricular arrhythmia, active ischemic heart disease, history of myocardial infarction within 1 year prior to screening), renal impairment, or respiratory disease

Trial locations and contacts

4 sites in 1 country.

subin kim contact

+82-2-2071-3310

sbkim@eutilex.com

South Korea4 sites, 4 recruiting

  • National Cancer Center

    Gyeonggi-do

    Bo-Hyun Kim, MD, PhD

    Recruiting

  • Severance Hospital

    Seoul

    Do-Young Kim, MD, PhD

    Recruiting

  • SoonChunHyang University Hospital Seoul

    Seoul

    Jae-Young Jang, MD, PhD

    Recruiting

  • The Catholic University of Korea Seoul ST.MARY'S Hospital.

    Seoul

    Pil-Soo Sung, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 Targeted Chimeric Antigen Receptor T Cell Therapy in Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Who Have Failed Standard Therapy

To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy

Read the detailed description

A Dose-escalation, Single-arm, Open-Label, Phase 1 Study

Being tested
EU307 CAR-T Cell
Keywords
GPC3, HCC, Hepatocellular Carcinoma, CAR-T
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EU307 CAR-T CellBiological

    • Dose to be administered: a single dose
    • IV administration
    • Dosing rate: To be administrated at a rate of approximately 2 mL/min
Study groups in NCT05783570
Study groupRoleWhat they receive
EU307 CAR-T CellExperimentalNot described
Receives: Biological: EU307 CAR-T Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs (including DLT)

    In this study, DLT is defined as an AE related to the IP (EU307),and severity will be assessed according to NCI-CTCAE v5.0

    Measured: up to 6 month from LPI

  2. Production of replication competent lentiviruses (RCL)

    Measured: up to 6 month from LPI

  3. Development of anti-drug antibodies (ADA)

    Measured: up to 6 month from LPI

Secondary outcomes (7)

  1. ORR

    Proportion of subjects with confirmed CR or partial response (PR) as best overall response (BOR)

    Measured: up to 6 month

  2. DoR

    Time from confirmed tumor response (CR or PR) to confirmed progressive disease (PD)

    Measured: up to 6 month

  3. DCR

    Proportion of subjects with confirmed CR, PR, or stable disease (SD) (≥ 6 weeks) as BOR

    Measured: up to 6 month

  4. TTR

    Time from IP dosing to confirmed objective response (CR or PR)

    Measured: up to 6 month

  5. TTP

    Time from IP dosing to PD

    Measured: up to 6 month

  6. PFS

    Time from IP dosing to PD or all-cause death, whichever is earlier

    Measured: up to 6 month

  7. OS

    Time from IP dosing to all-cause death

    Measured: up to 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start24 Aug 2023
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05783570
Sponsor's protocol ID
EU-CTS307-I-01
Status last verified
Mar 2024
First submitted
27 Feb 2023
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing EU307 CAR-T Cell in people with Advanced Hepatocellular Carcinoma, run by Eutilex at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact subin kim (+82-2-2071-3310, sbkim@eutilex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AEs (including DLT) (time frame: up to 6 month from LPI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05783570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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