Hepatocellular Carcinoma study: ECT204 T cells
Official title GPC3-Targeted T-Cell Therapy (ECT204) in Adults With Advanced HCC
ClinicalTrials.gov ID: NCT04864054
What this study is testing
What is ECT204 T cells?
ECT204 T cells is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking to find out if ECT204 is safe, tolerable, and effective for treating this type of liver cancer.
- Who it's for
- Adults with advanced GPC3‑positive hepatocellular carcinoma whose disease progressed after, or who cannot tolerate, prior systemic therapy.
- What's involved
- Participants will receive the investigational ECT204 T‑cell therapy and undergo regular clinic visits and tests to check safety and cancer response.
- Time commitment
- The trial runs for several months, with multiple scheduled visits and assessments throughout the study period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic.
- GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).
- For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.
- Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC.
- Must have received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.
You likely can't join if
- Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
- Active, uncontrolled systemic bacterial, fungal, or viral infection.
- History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ...
- Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease.
- Pregnant or lactating women.
- Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic...
See the full eligibility criteria
- Histologically confirmed HCC, that is unresectable, recurrent, and/or metastatic.
- GPC3-positive tumor expression confirmed by immunohistochemistry (IHC).
- For the dose-escalation cohort: ≥10-20% tumor cells, ≥2+ IHC.
- Beginning with the RP2D confirmatory cohort: ≥ 50% tumor cells, 2+/3+ IHC.
- Must have received at least first-line systemic therapy for HCC and have experienced disease progression on, or intolerance to, that therapy.
- Life expectancy of at least 4 months per the Investigator's opinion.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Measurable disease by RECIST v1.1.
- Child-Pugh score of A6 or better.
- Adequate organ function.
- Pre-existing illness (e.g., symptomatic congestive heart failure) that would limit compliance with study requirements.
- Active, uncontrolled systemic bacterial, fungal, or viral infection. people with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load...
- History of malignancy other than HCC within 5 years before screening, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancies with low risk of recurrence.
- Known brain metastases or other active central nervous system (CNS) involvement, including leptomeningeal disease.
- Pregnant or lactating women.
- Currently receiving or ending (\< 14 days from date of consent) liver tumor-directed therapy (e.g., radiation, ablation, embolization), or hepatic surgery.
- Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Presence of portal vein tumor thrombus (PVTT) classified as grade Vp4, or any invasion into the inferior vena cava (IVC), except for people with IVC invasion who have been treated and radiographically stable for at...
- Ascites requiring active treatment, such as a requirement for paracentesis or escalation of diuretic doses. Exception: people maintained on a stable dose of diuretics with controlled, asymptomatic ascites are eligible.
- Active gastrointestinal (GI) bleeding event ≥ Grade 3 per National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 5.0, within 6 months prior to screening.
- Coagulation abnormality defined as international normalized ratio (INR) \> 1.7, unless the elevation is due to therapeutic anticoagulation that, in the Investigator's judgment, can be safely managed in the context of...
- History of organ transplant.
- HCC involving greater than 50% of the liver volume.
- Experienced allergies to any component of the study drug (ECT204), mouse immunoglobulin, or iron-dextran, or have a history of severe hypersensitivity, including anaphylaxis.
- Previously received other gene therapy (e.g., chimeric antigen receptor T-cell [CAR-T] therapy); exception: prior oncolytic virus therapy is permitted.).
- Contraindication for undergoing leukapheresis procedure or receipt of conditioning agents
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- The Bronx, New York, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; The Bronx, New York, United States; Portland, Oregon, United States; Dallas, Texas, United States; Seattle, Washington, United States; Taipei, Taiwan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.