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New treatment option for Hepatoblastoma
Official title ET140203 T Cells in Pediatric Subjects With Hepatoblastoma, HCN-NOS, or Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT04634357
What this study is testing
What is ET140203 T Cells?
ET140203 T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatoblastoma.
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
- Open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety/tolerability and determine the recommended Phase II Dose (RP2D) of ET140203 T-cells in pediatric subjects who are AFP-positive/HLA-A2-positive and have relapsed/refractory HB, HCN-NOS, or HCC.
- 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 1 to 21
You may be able to join if
- Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \>100ng/mL at the time of screening and following the most recent line of therapy.
- Disease recurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e...
- Age ≥ 1 year and ≤ 21 years.
- Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.
- Life expectancy of \> 4 months per the Investigator's opinion.
You likely can't join if
- Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).
- Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation that would...
- Active, uncontrolled systemic bacterial, fungal, or viral infection. people with Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C are...
- Any known active malignancy (other than HB, HCN-NOS, or HCC).
- Pregnant or lactating women.
- Received the following within one (1) week of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation...
See the full eligibility criteria
- Histologically confirmed HB, HCN-NOS, or HCC with serum AFP \>100ng/mL at the time of screening and following the most recent line of therapy.
- Disease recurrence after remission following initial standard-of care (SOC) treatment (i.e., relapse) or failure of response to SOC treatment (i.e., refractory).
- Age ≥ 1 year and ≤ 21 years.
- Molecular Human Leukocyte Antigen (HLA) class I allele typing that confirms subject carries at least one HLA-A2 allele.
- Life expectancy of \> 4 months per the Investigator's opinion.
- Lansky or Karnofsky Performance Scale ≥ 70.
- For enrollment to the dose-finding cohort, people must have at least one (1) lesion ≥ 5 mm in diameter or two (2) or more lesions ≥ 3 mm in diameter. For the dose-expansion cohort, people must have measurable disease by...
- Child-Pugh score of A6 or better.
- Adequate organ function.
- Recurrent HB who are candidates for complete surgical resection (e.g., isolated pulmonary relapse amendable to pulmonary metastasectomy).
- Pre-existing illness including heart failure, uncontrolled pulmonary disease not cancer-related, or psychiatric illness/social situation 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...
- Any known active malignancy (other than HB, HCN-NOS, or HCC).
- Pregnant or lactating women.
- Received the following within one (1) week of leukapheresis or within two (2) weeks of conditioning chemotherapy: cytotoxic chemotherapy, radiation, other anti-cancer therapies (including immunotherapeutic agents), or...
- Concurrently receiving other investigational agents, biological, chemical, or radiation therapies, while participating in the study.
- Contraindication for receipt of conditioning chemotherapeutic agents including Fludarabine and Cyclophosphamide.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Compromised circulation in the main portal vein, hepatic vein, or vena cava due to partial or complete obstruction which, in the opinion of the Investigator, would make the subject unsuitable for the study.
- History of organ transplant.
- HB, HCN-NOS, or HCC involving greater than 50% of the liver (volumetric).
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Boston, Massachusetts, United States
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 - 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, 1 year to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.