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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

⁃ 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

Locations
Other Locations
Republic of Korea
National Cancer Center
RECRUITING
Gyeonggi-do
Severance Hospital
RECRUITING
Seoul
SoonChunHyang University Hospital Seoul
RECRUITING
Seoul
The Catholic University of Korea Seoul ST.MARY'S Hospital.
RECRUITING
Seoul
Contact Information
Primary
subin kim
sbkim@eutilex.com
+82-2-2071-3310
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2025-12
Participants
Target number of participants: 12
Treatments
Experimental: EU307 CAR-T Cell
Related Therapeutic Areas
Sponsors
Leads: Eutilex

This content was sourced from clinicaltrials.gov

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